Data / Medical devices / United States / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in Coventry, RI, United States, 270 510(k) clearances and 21 PMA approvals

Name: Boston Scientific Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific Corporation is registered with the FDA (registration 1000121056) in Coventry, RI, United States. It lists 127 device types. The FDA files 270 510(k) clearances and 21 PMA approvals under its listings, the newest dated September 3, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this one Watch Boston Scientific Corporation

FDA registration number: 1000121056
Address: 8 Industrial Dr, Coventry, RI, United States, 02816
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer, Manufacturer for export, Specification developer
First device listed: September 9, 1983
Registered through: 2027
Brand names listed: AngioJet Spiroflex Thrombecotmy Set, AngioJet Spiroflex VG Thrombectomy Set, AngioJet Ultra 5000A Console, AutoElite Thrombectomy System Console, Blazer II HTD Temperature Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II XP Temperature Ablation Catheter, Blazer Open-Irrigated Ablation Catheter and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Adaptor, Bulbs, Miscellaneous, For Endoscope	FFY	1	Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Aspiration Thrombectomy Catheter	QEZ	2	Manufacturer, Specification developer	accessdata.fda.gov
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection	GCA	2	Manufacturer	accessdata.fda.gov
Biliary Stent System For Benign Strictures	PNB	2	Manufacturer	accessdata.fda.gov
Biopsy Needle	FCG	2	Manufacturer	accessdata.fda.gov
Bottle, Collection, Vacuum	KDQ	2	Manufacturer	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Manufacturer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Manufacturer	accessdata.fda.gov
Brush, Biopsy, Bronchoscope (Non-Rigid)	BTG	2	Manufacturer	accessdata.fda.gov
Cable, Electrode	IKD	2	Manufacturer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Camera, Surgical And Accessories	KQM	1	Manufacturer	accessdata.fda.gov
Cardiac Ablation Percutaneous Catheter	LPB	3	Manufacturer	accessdata.fda.gov
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Catheter, Cholangiography	GBZ	1	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Coronary, Atherectomy	MCX	3	Manufacturer	accessdata.fda.gov
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Nephrostomy	LJE	U	Manufacturer	accessdata.fda.gov
Catheter, Nephrostomy, General & Plastic Surgery	GBO	1	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring	NWX	3	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Manufacturer	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Manufacturer	accessdata.fda.gov
Catheter, Septostomy	DXF	2	Manufacturer	accessdata.fda.gov
Catheter, Steerable	DRA	2	Manufacturer	accessdata.fda.gov
Catheter, Urethral	GBM	2	Manufacturer	accessdata.fda.gov
Catheter, Urological	KOD	2	Manufacturer	accessdata.fda.gov
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Choledochoscope And Accessories, Flexible/Rigid	FBN	2	Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Manufacturer	accessdata.fda.gov
Coronary Drug-Eluting Stent	NIQ	3	Manufacturer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Manufacturer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Dilator, Catheter	GCC	1	Manufacturer	accessdata.fda.gov
Dilator, Catheter, Ureteral	EZN	2	Manufacturer	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	Manufacturer	accessdata.fda.gov
Dilator, Urethral	KOE	2	Manufacturer	accessdata.fda.gov
Dilator, Vessel, For Percutaneous Catheterization	DRE	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Dislodger, Stone, Biliary	LQR	2	Manufacturer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Manufacturer	accessdata.fda.gov
Duodenoscope And Accessories, Flexible/Rigid	FDT	2	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Manufacturer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Manufacturer	accessdata.fda.gov
Endoscopic Cholangiogram Kit	NWT	2	Manufacturer	accessdata.fda.gov
Endoscopic Cytology Brush	FDX	2	Manufacturer	accessdata.fda.gov
Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	PTS	2	Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2	Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Endoscopic Retrograde Cholangiopancreatography (Ercp) Cannula	ODD	2	Manufacturer	accessdata.fda.gov
Endoscopic Suturing Device For Altering Gastric Anatomy For Weight Loss	QTD	2	Manufacturer	accessdata.fda.gov
Endoscopic Tissue Approximation Device	OCW	2	Manufacturer	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Manufacturer	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Manufacturer	accessdata.fda.gov
Esophageal Dilator Balloon With Or Without Electrode Sensors	PID	2	Manufacturer	accessdata.fda.gov
Evacuator, Gastro-Urology	KQT	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Gastrointestinal Tubes With Enteral Specific Connectors	PIF	2	Manufacturer	accessdata.fda.gov
Gynecological Laparoscopic Kit	OHD	2	Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Implantable Cardioverter Defibrillator (Non-Crt)	LWS	3	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Stress Urinary Incontinence	PWJ	2	Manufacturer	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse	PWI	2	Manufacturer	accessdata.fda.gov
Intracranial Neurovascular Stent	NJE	f	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Kit, Nephroscope	FGA	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Led Light Source	NTN	2	Manufacturer	accessdata.fda.gov
Lithotriptor, Biliary Mechanical	LQC	2	Manufacturer	accessdata.fda.gov
Lithotriptor, Electro-Hydraulic	FFK	2	Manufacturer	accessdata.fda.gov
Mechanical Thrombolysis Catheter	QEY	2	Manufacturer	accessdata.fda.gov
Medical Glove, Specialty	LZC	1	Manufacturer	accessdata.fda.gov
Mesh, Surgical, For Stress Urinary Incontinence, Male	OTM	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal And Uterine Prolapse, Transabdominally Placed	OTO	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Female, Mini-Sling	PAH	2	Manufacturer	accessdata.fda.gov
Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator	OTN	2	Manufacturer	accessdata.fda.gov
Needle, Catheter	GCB	1	Manufacturer	accessdata.fda.gov
Pancreatic Stent, Covered, Metallic, Removable	PCU	2	Manufacturer	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Manufacturer	accessdata.fda.gov
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3	Manufacturer	accessdata.fda.gov
Percutaneous Catheter, Ultrasound	PPN	2	Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer	accessdata.fda.gov
Permanent Defibrillator Electrodes	NVY	3	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Prosthesis, Esophageal	ESW	2	Manufacturer	accessdata.fda.gov
Prosthesis, Penile	FAE	2	Manufacturer	accessdata.fda.gov
Prosthesis, Tracheal, Expandable	JCT	2	Manufacturer	accessdata.fda.gov
Pump, Air, Non-Manual, For Endoscope	FEQ	2	Manufacturer	accessdata.fda.gov
Radiographic Protective Glove	IWP	1	Manufacturer	accessdata.fda.gov
Shunt, Portosystemic, Endoprosthesis	MIR	3	Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Stent, Central Venous	QKJ	3	Manufacturer	accessdata.fda.gov
Stent, Colonic, Metallic, Expandable	MQR	2	Manufacturer	accessdata.fda.gov
Stent, Coronary	MAF	3	Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	Manufacturer	accessdata.fda.gov
Stent, Metallic, Expandable, Duodenal	MUM	2	Manufacturer	accessdata.fda.gov
Stent, Renal	NIN	3	Manufacturer	accessdata.fda.gov
Stent, Superficial Femoral Artery	NIP	3	Manufacturer, Manufacturer for export	accessdata.fda.gov
Stent, Superficial Femoral Artery, Drug-Eluting	NIU	3	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Stylet For Catheter, Gastro-Urology	EZB	1	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	2	Manufacturer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Manufacturer	accessdata.fda.gov
System, Appendage Closure, Left Atrial	NGV	3	Manufacturer	accessdata.fda.gov
Temporary Carotid Catheter For Embolic Capture	NTE	2	Manufacturer	accessdata.fda.gov
Transducer, Pressure, Catheter Tip	DXO	2	Manufacturer	accessdata.fda.gov
Tube, Drainage, Suprapubic	FFA	2	Manufacturer	accessdata.fda.gov
Tubes, Gastrointestinal (And Accessories)	KNT	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter, Exempt	PTL	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance. Newest 100 of 270.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 3, 2026	K262460	Rezum System	KNS	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
August 26, 2026	K261153	LithoVue Elite Digital Flexible Ureteroscope System	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 4, 2026	K261915	Navigator Flex Ureteral Access Sheath Set	FED	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 17, 2026	K260428	RIVOS EUS Access Device (M00553900)	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 15, 2026	K260771	TruSelect 2.6 Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 9, 2025	K252910	Orca Air/Water and Suction Valves	ODC	Unknown	Boston Scientific	accessdata.fda.gov
September 24, 2025	K252703	LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard with pressure monitoring (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse with pressure monitoring (M0067940500)	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 9, 2025	K251759	Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers	GEX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 3, 2025	K251291	Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers	FGE	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
June 27, 2025	K250310	VIKING Fixed Curve Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 11, 2025	K250584	Rezum System	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 15, 2025	K250824	Percuflex Ureteral Stent; Percuflex Plus Ureteral Stent; Percuflex Plus SureDrive Steerable Ureteral Stent Set; Contour Ureteral Stent; Contour SureDrive Steerable Ureteral Stent Set; Contour VL Variable Length Ureteral Stent; Contour VL SureDrive Steerable Ureteral Stent Set; Polaris Ultra Ureteral Stent; Polaris Loop Ureteral Stent; Tria Firm Ureteral Stent; Tria Soft Ureteral Stent; Percuflex Urinary Diversion Stent Set	FAD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 25, 2025	K250225	Bolt Intravascular Lithotripsy (IVL) System	PPN	Substantially Equivalent	Bolt Medical, Inc.	accessdata.fda.gov
March 21, 2025	K250517	Navigator HD Ureteral Access Sheath Set 11/13 F x 28cm (M0062502210); Navigator HD Ureteral Access Sheath Set 11/13 F x 36cm (M0062502220); Navigator HD Ureteral Access Sheath Set 11/13 F x 46cm (M0062502230); Navigator HD Ureteral Access Sheath Set 12/14 F x 28cm (M0062502240); Navigator HD Ureteral Access Sheath Set 12/14 F x 36cm (M0062502250); Navigator HD Ureteral Access Sheath Set 12/14 F x 46cm (M0062502260); Navigator HD Ureteral Access Sheath Set 13/15 F x 28cm (M006	FED	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 20, 2025	K250468	iSLEEVE Introducer Set	DYB	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
February 6, 2025	K250066	Resolution Clip (M00522600); Resolution Clip (M00522601); Resolution Clip (M00522602); Resolution Clip (M00522610); Resolution Clip (M00522611); Resolution Clip (M00522612)	PKL	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 6, 2024	K242950	WallFlex Biliary PLUS RX Stent System	FGE	Unknown	Boston Scientific	accessdata.fda.gov
November 1, 2024	K242076	VersaCross RF Wire	DXF	Substantially Equivalent	Baylis Medical Company	accessdata.fda.gov
November 1, 2024	K240366	EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional Steerable Diagnostic Catheter; Dynamic XT Unidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 30, 2024	K240464	WallFlex Biliary RX Stent System; Epic Biliary Stent System; WallFlex Biliary RX Fully Covered Stent System RMV	FGE	Unknown	Boston Scientific	accessdata.fda.gov
July 12, 2024	K241720	VersaCross Connect Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
July 10, 2024	K241683	Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031404020 ); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031406020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031408020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031410020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031412020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H74939031415020); Sterling MONORAIL PTA Balloon Dilatation Catheter (H749390314	LIT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 1, 2024	K241598	LithoVue Elite Single-Use Digital Flexible Ureteroscope - Standard (with pressure monitoring) (M0067940000); LithoVue Elite Single-Use Digital Flexible Ureteroscope - Reverse (with pressure monitoring) (M0067940500); LithoVue Elite Single-Use Digital Flexible Ureteroscope Standard (without pressure monitoring) (M0067941000); LithoVue Elite Single-Use Digital Flexible Ureteroscope Reverse (without pressure monitoring) (M0067941500)	FGB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 29, 2024	K241207	SmartClaw Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw Thrombectomy Catheter, 32 mm (FD0660-02)	QEW	Substantially Equivalent	Devoro Medical, Inc.	accessdata.fda.gov
April 4, 2024	K233837	Agile Esophageal Stent System	ESW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 8, 2024	K234046	WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System	MQR	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 1, 2024	K240018	WATCHMAN TruSteer Access System (M635TU90050)	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 20, 2023	K231227	SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
December 14, 2023	K233647	VersaCross Connect Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
December 12, 2023	K233645	StoneSmart Connect Console, LithoVue Elite Standard Deflection, LithoVue Elite Reverse Deflection	FGB	Substantially Equivalent	Boston Scientific Corporation -	accessdata.fda.gov
December 11, 2023	K233248	FARADRIVE Steerable Sheath	DRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 30, 2023	K233503	14F iSLEEVE Introducer Set	DYB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 27, 2023	K233318	AXIOS Stent and Electrocautery-Enhanced Delivery System (6mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (8mmx8mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (10mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (20mmx10mm); AXIOS Stent and Electrocautery-Enhanced Delivery System (15mmx15mm)	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 27, 2023	K233207	Polaris X Unidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 29, 2023	K232651	BLAZER Dx-20 Bidirectional Steerable Diagnostic Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 18, 2023	K232544	Apollo ESG NXT System, Apollo REVISE NXT System	QTD	Substantially Equivalent	Apollo Endosurgery, Inc.	accessdata.fda.gov
August 14, 2023	K232162	Autotome Pro RX 39 Sphincterotome; Autotome Pro RX 44 Sphincterotome; Jagtome Pro RX 44 Sphincterotome; Jagtome Pro RX 39 Sphincterotome; Dreamtome Pro RX 44 Sphincterotome; Hydratome Pro RX 44 Sphincterotome; Jagtome Revolution Pro RX 39 Sphincterotome	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 8, 2023	K223633	Rubicon Control Support Catheter (H749394323506A1)	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 14, 2023	K230269	Ultraflex Tracheobronchial Stent System	JCT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 29, 2023	K231553	OverStitch NXT Endoscopic Suturing System	OCW	Substantially Equivalent	Apollo Endosurgery, Inc.	accessdata.fda.gov
June 29, 2023	K231549	Advantage Ultra System, Advantage Fit Ultra System, Lynx Ultra System	OTN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 27, 2023	K230706	EMBOLD Soft Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 21, 2023	K231533	Habib EndoHPB	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 15, 2023	K223469	WallFlex Biliary RX Stent System	FGE	Unknown	Boston Scientific Corporation	accessdata.fda.gov
May 25, 2023	K231176	Stingray LP Catheter	DQY	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 25, 2023	K230503	Polaris X Catheter Cable, Blazer Dx-20 Catheter Cable	DRF	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 11, 2023	K230402	ENROUTE® Transcarotid Neuroprotection System	NTE	Substantially Equivalent	Silk Road Medical	accessdata.fda.gov
March 22, 2023	K223824	POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE Pressure Sensor	DRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 30, 2022	K223616	Acquire S Endoscopic Ultrasound Fine Needle Biopsy (FNB) Device	ODG	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 29, 2022	K223592	Advanix Pancreatic Stent and NaviFlex Rapid Exchange (RX) Pancreatic Delivery System and Pushers	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 10, 2022	K211934	APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System Kit with Dissolving Tip, Flexima Quickstick Drainage Catheter System, vanSonnenberg Drainage Cateter System, vanSonnenberg	FAD	Unknown	Boston Scientific Corporation	accessdata.fda.gov
September 14, 2022	K222503	Resolution Clip, Resolution 360 Clip, Resolution 360 ULTRA Clip	PKL	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 6, 2022	K220962	ROTAPRO Rotational Atherectomy System	MCW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 2, 2022	K221414	ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter	LIT	Substantially Equivalent	Silk Road Medical, Inc.	accessdata.fda.gov
August 4, 2022	K221124	MANTIS Clip	PKL	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 12, 2022	DEN210045	APOLLO ESG System, APOLLO ESG SX System, APOLLO REVISE System, APOLLO REVISE SX System	QTD	Unknown	Apollo Endosurgery, Inc.	accessdata.fda.gov
June 30, 2022	K213582	Epicardial Access System	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
June 10, 2022	K220796	IntellaMap Orion High Resolution Mapping Catheter	DRF	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 9, 2022	K220414	VersaCross Connect Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 6, 2022	K212582	SpyGlass Discover Balloon Dilation Catheter	GCA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 20, 2022	K220866	EKOS+ Endovascular Device	QEY	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 12, 2022	K213398	EMBOLD Fibered Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 24, 2022	K220629	Emerge Monorail PTCA Dilatation Catheter	LOX	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
December 20, 2021	K211847	AdVance XP Male Sling System	OTM	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 14, 2021	K213422	EkoSonic Endovascular Device, EKOS+ Endovascular Device	QEY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 13, 2021	K212228	WATCHMAN FXD Curve Access System	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 26, 2021	K203322	SpyGlass Discover Retrieval Basket	LQR	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 6, 2021	K210353	AutoCap RX	ODC	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 27, 2021	K211072	Safety Trocar Cannula	KNT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 18, 2020	K203162	Advanix Biliary Stent with NaviFlex RX Delivery System	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 15, 2020	K201808	X-Tack Endoscopic HeliX Tacking System	PKL	Substantially Equivalent	Apollo Endosurgery, Inc.	accessdata.fda.gov
December 3, 2020	K200404	ORISE ProKnife	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 8, 2020	K202478	Captivator Single-Use Polypectomy Snares, Captiflex Single-Use Polypectomy Snares	FDI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 2, 2020	K202218	ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device	QEW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 15, 2020	K201170	Athletis PTA Balloon Dilatation Catheter	LIT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 28, 2020	K201792	TRUSELECT Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 12, 2020	K201288	ExpanSure Large Access Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 21, 2020	K200483	SpyGlass Discover Digital Catheter, SpyGlass Discover Digital Controller	FBN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
January 2, 2020	K191446	Ureteral Stent Systems, Biliary Drainage Catheters	FAD	Unknown	Boston Scientific Corporation	accessdata.fda.gov
December 23, 2019	K193279	Comet II Pressure Guidewire	DXO	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 13, 2019	K193202	EXALT Model D Single-Use Duodenoscope, EXALT Controller	FDT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 29, 2019	K191439	OverStitch 2-0 Polypropylene Suture	OCW	Substantially Equivalent	Apollo Endosurgery	accessdata.fda.gov
July 25, 2019	K191789	Stonetome Stone Removal Device	LQR	Unknown	Boston Scientific Corporation	accessdata.fda.gov
June 7, 2019	K183649	Diagnostic Fixed Electrophysiology Catheter, Diagnostic Electrophysiology Cable	DRF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
June 7, 2019	K183632	Diagnostic Fixed Electrophysiology Lumen Catheter , Diagnostic Electrophysiology Cable	DRF	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
May 20, 2019	K183655	VersaCross Transseptal Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 17, 2019	K190688	VersaCross Steerable Sheath, VersaCross Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 16, 2019	K183619	Tactra Penile Prosthesis, 9.5 mm Device, Tactra Penile Prosthesis, 11 mm Device, Tactra Penile Prosthesis, 13 mm Device	FAE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 25, 2019	K181905	AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System	PCU	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 15, 2019	K190401	MAMBA and MAMBA Flex Microcatheters	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 8, 2019	K183177	Nitinol Thermocouple (TCN) Electrode	GXI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 8, 2019	K183085	CoreDx Pulmonary Mini-Forceps	EOQ	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
January 22, 2019	K183636	SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller	FBN	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 26, 2018	K182324	EkoSonic Endovascular System	QEY	Substantially Equivalent	Btg International, Inc.	accessdata.fda.gov
September 26, 2018	K182315	Magic Torque DLVR Guidewire	DQX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 27, 2018	K181141	OverStitch Endoscopic Suturing System and Accessories	OCW	Substantially Equivalent	Apollo Endosurgery	accessdata.fda.gov
June 18, 2018	K180726	Savion DLVR Guidewire, Savion FLX Guidewire	DQX	Substantially Equivalent	Boston Scientific, Inc.	accessdata.fda.gov
April 12, 2018	K180795	JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire	DQX	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
December 20, 2017	K172565	Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device	PWJ	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 15, 2017	K171271	Polyform Synthetic Mesh	OTO	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
March 10, 2026	P130030	REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE	MAF	75	March 10, 2026	accessdata.fda.gov
January 30, 2024	P230030	FARAPULSE Pulsed Field Ablation System (FARAWAVE Pulsed Field Ablation Catheter, FARASTAR Catheter Connection Cable,	QZI	24	October 2, 2026	accessdata.fda.gov
August 8, 2023	P220032	POLARx/POLARx FIT Cryoablation Catheters, SMARTFREEZE Cryoablation Console, Accessories	OAE	12	May 29, 2026	accessdata.fda.gov
October 30, 2020	P190019	Ranger Paclitaxel-Coated PTA Balloon Catheter	ONU	41	August 4, 2026	accessdata.fda.gov
September 18, 2018	P180011	Eluvia Drug-Eluting Vascular Stent System	NIU	67	August 21, 2026	accessdata.fda.gov
February 24, 2016	P150005	BLAZER OPEN-IRRIGATED ABLATION CATHETER	OAD	91	December 5, 2025	accessdata.fda.gov
October 2, 2015	P150003	SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM	NIQ	109	August 21, 2026	accessdata.fda.gov
July 21, 2015	P140028	INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM	NIP	86	August 21, 2026	accessdata.fda.gov
March 13, 2015	P130013	WATCHMAN LEFT ATRIAL APPENDAGE (LAA) CLOSURE TECHNOLOGY	NGV	84	August 28, 2026	accessdata.fda.gov
April 13, 2012	P110035	EPIC SELF-EXPANDING NITINOL STENT SYSTEM	NIO	76	August 21, 2026	accessdata.fda.gov
November 22, 2011	P110010	PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM	NIQ	207	January 14, 2025	accessdata.fda.gov
December 11, 2008	P060006	BOSTON SCIENTIFIC EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM	NIN	104	December 12, 2023	accessdata.fda.gov
August 25, 2003	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	141	October 17, 2025	accessdata.fda.gov
November 16, 2001	P980033	WALLSTENT ENDOPROSTHESIS	QKJ	65	May 6, 2026	accessdata.fda.gov
April 18, 2000	P950020	FLEXATOME CUTTING BALLOON	NWX	139	January 27, 2026	accessdata.fda.gov
March 12, 1999	P980037	ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER	MCX	93	August 1, 2025	accessdata.fda.gov
May 28, 1996	P940019	WALLSTENT(R) ILIAC ENDOPROSTHESIS	NIO	63	May 6, 2026	accessdata.fda.gov
September 29, 1995	P930031	WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	MIR	72	June 27, 2024	accessdata.fda.gov
October 28, 1994	P920047	EPT-1000 CARDIAC ABLATION SYSTEM	LPB	133	October 17, 2025	accessdata.fda.gov
August 26, 1993	P910073	ENDOTAK LEAD SYSTEM	LWS	179	September 17, 2026	accessdata.fda.gov
May 28, 1993	P900056	ROTABLATOR(R)	MCX	219	October 21, 2026	accessdata.fda.gov

Compare with other makers

Updated September 3, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.