Data / Medical devices / Costa Rica / Boston Scientific Corporation

Boston Scientific Corporation: FDA-registered device maker in El Coyol Alajuela, Costa Rica, 84 510(k) clearances and 4 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 3007695959) in El Coyol Alajuela, Costa Rica. It lists 58 device types. The FDA files 84 510(k) clearances and 4 PMA approvals under its listings, the newest dated April 8, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Boston Scientific Corporation

FDA registration number: 3007695959
Address: 2546 First Street, Propark, El Coyol Alajuela, Costa Rica, 20904
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer
First device listed: July 22, 1992
Registered through: 2026
Brand names listed: Blazer II HTD Temperature Ablation Catheter, Blazer II Temperature Ablation Catheter, Blazer II XP Temperature Ablation Catheter, Blazer Prime HTD Temperature Ablation Catheter, Blazer Prime XP Temperature Ablation Catheter, Blazer Solid-Tip Ablation Cather Cable, Sterile Cable, Blazer Solid-Tip Ablation Catheter Cable, Sterile Cable, Cable IntellaTip MiFi XP Sterile Cable and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Catheter	KGZ	1	Manufacturer	accessdata.fda.gov
Adaptor, Catheter	GCE	1	Manufacturer	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Manufacturer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Manufacturer	accessdata.fda.gov
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2	Manufacturer	accessdata.fda.gov
Cardiac Ablation Percutaneous Catheter	LPB	3	Manufacturer	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, 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, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3	Manufacturer	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Manufacturer	accessdata.fda.gov
Catheter, Ultrasound, Intravascular	OBJ	2	Manufacturer	accessdata.fda.gov
Connector, Ureteral Catheter	EYK	1	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
Duodenoscope And Accessories, Flexible/Rigid	FDT	2	Manufacturer	accessdata.fda.gov
Echocardiograph	DXK	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 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 Video Imaging System/Component, Gastroenterology-Urology	FET	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Bronchoscope (Non-Rigid)	BWH	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Non-Electric	FCL	1	Manufacturer	accessdata.fda.gov
Generator, Lesion, Radiofrequency	GXD	2	Manufacturer	accessdata.fda.gov
Hemostatic Metal Clip For The Gi Tract	PKL	2	Manufacturer	accessdata.fda.gov
Holder, Needle, Gastroenterologic	FHQ	1	Manufacturer	accessdata.fda.gov
Implant, Intragastric For Morbid Obesity	LTI	3	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Instrumentation, Surgical Mesh, Urogynecologic, Transvaginal Repair Of Pelvic Organ Prolapse	PWI	2	Manufacturer	accessdata.fda.gov
Introducer, Catheter	DYB	2	Manufacturer	accessdata.fda.gov
Laparoscope, General & Plastic Surgery	GCJ	2	Manufacturer	accessdata.fda.gov
Ligator, Esophageal	MND	2	Manufacturer	accessdata.fda.gov
Ligator, Hemorrhoidal	FHN	2	Manufacturer	accessdata.fda.gov
Mechanical Thrombolysis Catheter	QEY	2	Manufacturer	accessdata.fda.gov
Percutaneous Atrial Catheter Kit	OFK	2	Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer	accessdata.fda.gov
Probe, Radiofrequency Lesion	GXI	2	Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Manufacturer	accessdata.fda.gov
Snare, Non-Electrical	FGX	1	Manufacturer	accessdata.fda.gov
Stent, Ureteral	FAD	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
Stylet For Catheter, Gastro-Urology	EZB	1	Manufacturer	accessdata.fda.gov
Surgical Instruments, G-U, Manual (And Accessories)	KOA	1	Manufacturer	accessdata.fda.gov
Temporary Carotid Catheter For Embolic Capture	NTE	2	Manufacturer	accessdata.fda.gov
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	PUM	2	Manufacturer	accessdata.fda.gov
Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection	NFA	2	Manufacturer	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Manufacturer	accessdata.fda.gov
Tube, Drainage, Suprapubic	FFA	2	Manufacturer	accessdata.fda.gov
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2	Manufacturer	accessdata.fda.gov
Wire, Guide, Catheter	DQX	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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 8, 2026	K260816	OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)	OBJ	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
September 26, 2025	K252921	Radial Jaw 4 Pulmonary Biopsy Forceps	BWH	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
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
February 1, 2024	K240018	WATCHMAN TruSteer Access System (M635TU90050)	DQY	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
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
June 29, 2023	K231553	OverStitch NXT Endoscopic Suturing System	OCW	Substantially Equivalent	Apollo Endosurgery, Inc.	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 23, 2022	K222568	OptiCross 18 Peripheral Imaging Catheter	OBJ	Substantially Equivalent	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
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
May 9, 2022	K220414	VersaCross Connect Transseptal Dilator	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 20, 2022	K220866	EKOS+ Endovascular Device	QEY	Substantially Equivalent	Boston Scientific	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
December 15, 2020	K201808	X-Tack Endoscopic HeliX Tacking System	PKL	Substantially Equivalent	Apollo Endosurgery, Inc.	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
June 12, 2020	K201288	ExpanSure Large Access Transseptal Dilator	DRE	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 17, 2020	K200733	Opticross 35 15 MHz Peripheral Imaging Catheter	ITX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 19, 2020	K192460	Sentinel Cerebral Protection System	PUM	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 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
May 20, 2019	K183655	VersaCross Transseptal Sheath	DYB	Substantially Equivalent	Baylis Medical Company, Inc.	accessdata.fda.gov
April 5, 2019	K183361	EkoSonic Endovascular Device with Control Unit 4.0	QEY	Substantially Equivalent	Btg International, Inc.	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
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
May 17, 2018	K181042	Ultra ICE Plus PI 9 MHz Peripheral Imaging Catheter	DXK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 12, 2018	K180795	JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire	DQX	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
November 3, 2017	K172060	Capio SLIM Suture Capturing Device	PWI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 7, 2017	K171454	Interject Injection Therapy Needle Catheter	FBK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
March 30, 2016	K160637	Rotatable Snares	FDI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 26, 2016	K160173	Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU)	DXK	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 12, 2016	K152231	Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire	DQX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 16, 2015	K151840	Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire	DQX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 3, 2015	K152580	rescuenet	FDI	Substantially Equivalent	Endochoice, Inc.	accessdata.fda.gov
January 15, 2015	K143587	ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire	DQX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 21, 2014	K140726	CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 1, CAPTIVATOR EMR DEVICE FOR STANDARD GASTROSCOPES - BOX 5, CAPTIV	FDI	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 21, 2014	K140151	EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT	QEY	Substantially Equivalent	Btg International, Inc.	accessdata.fda.gov
April 2, 2014	K133933	INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
January 24, 2014	K133987	CAPTIVATOR II,SINGLE-USE POLYPECTOMY SNARES	FDI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 4, 2013	K131700	SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES	FDI	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
September 13, 2012	K121774	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH PERIPHERAL ROTALINK PLUS	MCW	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 17, 2012	K122203	TRUETOME	KNS	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 3, 2011	K111705	EKOSONIC ENDOVASCULAR SYSTEM	QEY	Substantially Equivalent	Ekos Corporation	accessdata.fda.gov
October 5, 2010	K101657	RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40	KGE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
October 16, 2008	K082051	COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4	GXD	Substantially Equivalent	Cosman Medical, Inc.	accessdata.fda.gov
October 14, 2008	K082012	COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN	GXI	Substantially Equivalent	Cosman Medical, Inc.	accessdata.fda.gov
December 5, 2006	K063313	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (3.5 MM TO 5.5 MM)	NTE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 11, 2006	K061332	FILTERWIRE EZ EMBOLIC PROTECTION SYSTEM (2.25 MM-3.5 MM)	NFA	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 2, 2006	K060799	COSMAN CSK RF CANNULA; COSMAN RFK RF CANNULA	GXI	Substantially Equivalent	Cosman Medical, Inc.	accessdata.fda.gov
March 17, 2005	K050084	COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT;	GXI	Substantially Equivalent	Cosman Medical, Inc.	accessdata.fda.gov
May 21, 2003	K030617	PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE	DQX	Substantially Equivalent	Boston Scientific Scimed, Inc.	accessdata.fda.gov
December 20, 2002	K023870	FLEXIMA BILIARY CATHETER	FGE	Substantially Equivalent	Boston Scientific/Medi-Tech	accessdata.fda.gov
April 5, 2002	K020765	MICROVASIVE ZERO TIP AIRWAY RETRIEVAL BASKET, MODELS M00513200 AND M00513210	KTI	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
February 11, 2002	K020283	BACK-UP MEIER STEERABLE GUIDEWIRE	DQX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
January 11, 2002	K013598	REUSE CLAIM FOR THE BARD ELECTROPHYSIOLOGY SURELINK, TEMPLINK, AND TEMPLINK M EXTENSION CABLES	DSA	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
October 19, 2001	K013153	AUTOTOME RX MODEL # 4515, 4516	KNS	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
February 9, 1998	K974541	MODIFIED URETERAL INDWELLING CATHETER/STENT	FAD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
December 5, 1997	K973826	SPHINCTEROTOME	KNS	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
October 23, 1997	K971265	VIKING DIAGNOSTIC ELECTRODE CATHETER	DRF	Substantially Equivalent	C.R. Bard, Inc.	accessdata.fda.gov
April 11, 1997	K970278	MICROVASIVE GOLD PROBE	KNS	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
February 10, 1997	K970054	TANDEMRX	GCJ	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
June 5, 1995	K945379	PLATINUM PLUS GUIDEWIRE WITH HYDROPHILIC COATING	DQX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
December 8, 1994	K944290	CATHETERS, BILIARY CATHETERS, UROLOGICAL	FFA	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
December 8, 1994	K942453	GUIDE WIRE	DQX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
June 17, 1994	K935997	PLATINUM PLUS GUIDEWIRE	DQX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 12, 1994	K932553	DISPOSABLE SUTURE PLACEMENT SYSTEM	GCJ	Substantially Equivalent	Laurus Medical Corp.	accessdata.fda.gov
January 26, 1994	K933334	MAGIC TORQUE GUIDEWIRE	DQX	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
January 26, 1994	K924608	HYDROGEL COATED PERCUFLEX(R) DRAINAGE CATHETERS	FGE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
April 27, 1993	K930022	SPHINCTEROTOME	FDI	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
November 28, 1983	K833417	ENDOSCOPIC RETROGRADE	ODD	Substantially Equivalent	Microvasive	accessdata.fda.gov
April 26, 1982	K820870	URETERAL STANT SET	FAD	Substantially Equivalent	Van-Tec, Inc.	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
August 5, 2015	P140008	ORBERA INTRAGASTRIC BALLOON	LTI	23	January 5, 2026	accessdata.fda.gov
August 25, 2003	P020025	EP TECHNOLOGIES EPT-1000 XP RF ABLATION SYSTEM	OAD	141	October 17, 2025	accessdata.fda.gov
October 28, 1994	P920047	EPT-1000 CARDIAC ABLATION SYSTEM	LPB	133	October 17, 2025	accessdata.fda.gov
May 28, 1993	P900056	ROTABLATOR(R)	MCX	219	October 21, 2026	accessdata.fda.gov

Compare with other makers

Updated April 8, 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.