Data / Medical devices / Ireland / Boston Scientific Limited

Boston Scientific Limited: FDA-registered device maker in CORK Munster, Ireland, 52 510(k) clearances and 1 PMA approval

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

Boston Scientific Limited is registered with the FDA (registration 9616684) in CORK Munster, Ireland. It lists 31 device types. The FDA files 52 510(k) clearances and 1 PMA approval under its listings, the newest dated September 11, 2026. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9616684
FEI number: 3002913962
Address: Business and Technology Park Model Farm Road, CORK Munster, Ireland, --
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer
First device listed: August 22, 2006
Registered through: 2027
Brand names listed: ROTAPRO Advancer Burr Advancing Device, ROTAPRO Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device, ROTAPRO Rotational Atherectomy System Console Kit, ROTAWIRE Drive and wireClip Torquer Extra Support, ROTAWIRE Drive and wireClip Torquer Floppy, RotaLink Advancer Catheter Advancing Device, RotaLink Burr Exchangeable Burr Catheter, RotaLink Plus Pre-Connected Exchangeable Burr Catheter and Burr Advancing Device and more

Devices it lists

Device	Product code	Class	Role	Source
Accelerator, Linear, Medical	IYE	2	Manufacturer	accessdata.fda.gov
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Manufacturer	accessdata.fda.gov
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2	Manufacturer	accessdata.fda.gov
Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	NOY	2	Manufacturer	accessdata.fda.gov
Agents, Embolic, For Treatment Of Uterine Fibroids	NAJ	2	Manufacturer	accessdata.fda.gov
Bronchoscope Accessory	KTI	2	Manufacturer	accessdata.fda.gov
Catheter, Continuous Flush	KRA	2	Manufacturer	accessdata.fda.gov
Catheter, Coronary, Atherectomy	MCX	3	Manufacturer	accessdata.fda.gov
Catheter, Intravascular Occluding, Temporary	MJN	2	Manufacturer	accessdata.fda.gov
Catheter, Intravascular, Diagnostic	DQO	2	Manufacturer	accessdata.fda.gov
Catheter, Percutaneous	DQY	2	Manufacturer	accessdata.fda.gov
Catheter, Peripheral, Atherectomy	MCW	2	Manufacturer	accessdata.fda.gov
Catheter, Ureteral, Gastro-Urology	EYB	2	Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Manufacturer	accessdata.fda.gov
Device, Neurovascular Embolization	HCG	2	Manufacturer	accessdata.fda.gov
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Dilator, Esophageal	KNQ	2	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 Irrigation/Suction System	OCX	2	Manufacturer	accessdata.fda.gov
Hydrogel Spacer	OVB	2	Manufacturer	accessdata.fda.gov
Lavage, Jet	FQH	2	Manufacturer	accessdata.fda.gov
Peripheral Mechanical Thrombectomy With Aspiration	QEW	2	Manufacturer	accessdata.fda.gov
Powered Laser Surgical Instrument	GEX	2	Manufacturer	accessdata.fda.gov
Stents, Drains And Dilators For The Biliary Ducts	FGE	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation	MAV	2	Manufacturer	accessdata.fda.gov
Syringe, Balloon Inflation, Exempt	PTM	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
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.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 11, 2026	K262151	SpaceOAR Flex System	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 3, 2026	K262460	Rezum System	KNS	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
May 15, 2026	K260771	TruSelect 2.6 Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 10, 2026	K260119	SpaceOAR Vue System (SV-2101)	OVB	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
June 11, 2025	K250584	Rezum System	KNS	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
September 6, 2022	K220962	ROTAPRO Rotational Atherectomy System	MCW	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 12, 2022	K213398	EMBOLD Fibered Detachable Coil System	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 20, 2021	K203276	Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)	NOY	Substantially Equivalent	Biocompatibles UK Ltd (Part of Boston Scientific Corporation	accessdata.fda.gov
December 3, 2020	K200404	ORISE ProKnife	KNS	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 28, 2020	K202224	SpaceOAR System	OVB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 28, 2020	K201792	TRUSELECT Microcatheter	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
July 19, 2019	K182971	SpaceOAR Vue Hydrogel	OVB	Substantially Equivalent	Augmenix, Inc.	accessdata.fda.gov
March 15, 2019	K190401	MAMBA and MAMBA Flex Microcatheters	DQY	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 19, 2018	K180102	Embozene Color-Advanced Microspheres	NOY	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
December 19, 2017	K173251	LumiCoil Platinum Fiducial Marker	IYE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
November 9, 2017	K172453	WATCHDOG Hemostasis Valve Kit	DQX	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
October 4, 2017	K172520	CRE RX Biliary Balloon Dilatation Catheter	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
June 23, 2017	K170759	CRE Pulmonary Balloon Dilatation Catheter	KTI	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
May 16, 2017	K163701	Direxion and Direxion HI-FLO Torqueable Microcatheters	KRA	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 16, 2016	K162373	LC Bead LUMI	KRD	Substantially Equivalent	Biocompatibles UK Limited	accessdata.fda.gov
May 19, 2016	K160403	SmartStart Air/Water and Suction Valves	ODC	Substantially Equivalent	Endochoice, Inc.	accessdata.fda.gov
December 11, 2015	K152157	LC Bead LUMI	KRD	Substantially Equivalent	Biocompatibles UK , Ltd.	accessdata.fda.gov
October 8, 2014	K141378	IDC INTERLOCKING DETACHABLE COIL	KRD	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
August 27, 2014	K133023	JETSTREAM XC 2.4/3.4; JETSTREAM XC 2.1/3.0; JETSTREAM SC 1.85; JETSTREAM SC 1.6	MCW	Substantially Equivalent	Medrad, Inc.	accessdata.fda.gov
August 7, 2014	K141209	EMBOZENE COLOR-ADVANCED MICROSPHERES, EMBOZENE OPAQUE (NON-COLORED) MICROSPHERES, ONCOZENE MICROSPHERES	KRD	Substantially Equivalent	Celonova Biosciences, Inc.	accessdata.fda.gov
July 22, 2014	K140273	EQUALIZER OCCLUSION BALLOON CATHETER	MJN	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 15, 2014	K140329	RENEGADE HI-FLO MICROCATHETER, MICROCATHETER KIT, FATHOM SYSTEM, FATHOM KIT	KRA	Substantially Equivalent	Boston Scientific	accessdata.fda.gov
April 17, 2014	K140745	ENCORE 26 ADVANTAGE KIT	MAV	Unknown	Boston Scientific Corp	accessdata.fda.gov
January 8, 2014	K133750	OCCLUDER OCCLUSION BALLOON CATHETER	EYB	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
December 20, 2013	K133566	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM WITH THE PERIPHERAL ROTALINK PLUS	MCW	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
November 14, 2013	K133208	INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM	KRD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
October 22, 2013	K132990	OCCLUSION BALLOON CATHETER	MJN	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
September 13, 2013	K132578	INTERLOCK - 18 FIBERED IDC OCCLUSION SYSTEM	KRD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 9, 2013	K130484	MAXFORCE BILIARY DILATATION CATHETER AND HURRICANE RX BILIARY CATHETER	FGE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
May 16, 2013	K130909	GATEWAY ADVANAGE Y-ADAPTER	OCX	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
February 10, 2012	K112994	CRE DITATATION BALLON	FGE	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
September 28, 2011	K111475	AURIGA XL	GEX	Substantially Equivalent	Starmedtec GmbH	accessdata.fda.gov
April 20, 2011	K110833	CRE BALLOON DILATATION CATHETER	FDT	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
February 11, 2011	K102714	COMPLEX HELICAL 18, MULTI-LOOP 18, FIGURE 8-18, STRAIGHT 18 FIBERED PLATINUM COILS, VORTX -18, VORTX 35 & 2D HELICAL	KRD	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
August 23, 2010	K102082	EXTRACTOR PRO RX RETRIEVAL BALLONS, EXTRACTOR PRO XL RETRIEVAL BALLONS, EXTRACTOR PRO DL RETRIEVAL BALLONS MODEL M005470	FGE	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
April 16, 2010	K100663	CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321	NAJ	Substantially Equivalent	Boston Scientific Corporation	accessdata.fda.gov
April 16, 2010	K094018	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	HCG	Substantially Equivalent	Biocompatibles UK Limited	accessdata.fda.gov
December 24, 2008	K083091	LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES	KRD	Substantially Equivalent	Biocompatibles UK Limited	accessdata.fda.gov
November 26, 2002	K023681	RENEGADE STC 18 MICROCATHETER	DQO	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
January 29, 2002	K020012	MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER	DQO	Substantially Equivalent	Boston Scientific/Medi-Tech	accessdata.fda.gov
April 7, 2000	K000177	RENEGADE HI-FLO MICROCATHETER	KRA	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
November 19, 1997	K973645	RENEGADE FIBER BRAIDED MICROCATHETER	KRA	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
December 8, 1992	K922573	10 AND 20 CC INFLATION/DEFLATION DEVICES W/GAUGE	MAV	Substantially Equivalent	Boston Scientific Corp	accessdata.fda.gov
November 25, 1991	K913871	FLOSWITCH(R) HP	DQO	Substantially Equivalent	Boston Scientific Corp	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
May 28, 1993	P900056	ROTABLATOR(R)	MCX	219	October 21, 2026	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
September 16, 2026	99906	Class II	Ongoing	Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105; Material Number: M001195200	The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser cutting misalignment.	accessdata.fda.gov

Compare with other makers

Updated October 22, 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.