Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9616684

FEI Number

3002913962

Entity Name

Boston Scientific Limited

City/State/Country

CORK Munster, IE

Establishment Address

Business and Technology Park, Model Farm Road, CORK Munster --, IE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Boston Scientific Corporation (Owner Number: 9912058)

Owner / Operator Contact Address

300 Boston Scientific Way, Marlborough, MA 01752, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K132990

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2014-10-21
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2013-10-28
KTI	Bronchoscope Accessory	Ear, Nose, Throat	Class 2	874.4680	2017-06-30
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2010-09-09
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2015-10-13
QEW	Peripheral Mechanical Thrombectomy With Aspiration	Cardiovascular	Class 2	870.5150	2015-10-13
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2008-01-03
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2022-04-12
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2016-12-05
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2018-01-03
ODC	Endoscope Channel Accessory	Gastroenterology, Urology	Class 2	876.1500	2016-12-22
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-30
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2020-08-05
PTM	Syringe, Balloon Inflation, Exempt	Cardiovascular	Class 2	870.1650	2018-05-08
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-09-27
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2013-06-04
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2021-10-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2021-10-04
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2021-10-04
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2021-10-04
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2012-12-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2012-12-13
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2014-02-18
FDF	Colonoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-24
FDT	Duodenoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2014-04-24
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2014-04-24
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2017-10-13
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2013-11-20
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2026-05-21
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
MAV	Syringe, Balloon Inflation	Cardiovascular	Class 2	870.1650	2014-09-26
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2019-08-29
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
OVB	Hydrogel Spacer	Radiology	Class 2	892.5725	2026-03-17
FGE	Stents, Drains And Dilators For The Biliary Ducts	Gastroenterology, Urology	Class 2	876.5010	2012-05-08
DTL	Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	Cardiovascular	Class 2	870.4290	2017-11-14
DQX	Wire, Guide, Catheter	Cardiovascular	Class 2	870.1330	2017-11-14
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2016-01-27
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2016-01-27
DQO	Catheter, Intravascular, Diagnostic	Cardiovascular	Class 2	870.1200	2008-01-11
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2006-08-22
MCW	Catheter, Peripheral, Atherectomy	Cardiovascular	Class 2	870.4875	2012-09-24
EYB	Catheter, Ureteral, Gastro-Urology	Gastroenterology, Urology	Class 2	876.5130	2014-07-22
KRA	Catheter, Continuous Flush	Cardiovascular	Class 2	870.1210	2014-11-10
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2013-11-13

Official Correspondent

No official correspondent registered.

US Agent Details

Aaron Dunbar Business: Boston Scientific Corporation Email: aaron.dunbar@bsci.com Phone: (651) 3961414

Related Public Records

Same Entity

Boston Scientific Corporation

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025434462	Obsidio Inc	Maple Grove, MN, US
3005619880	Boston Scientific Corporation	Roswell, GA, US
3015425075	NALU MEDICAL	Carlsbad, CA, US
3015289131	FARAPULSE, INC.	Menlo Park, CA, US
3022298579	Boston Scientific Cardiac Diagnostic Technologies, Inc.	Arden Hills, MN, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K051067	LeMaitre Vascular, Inc.	PRUITT F3 OUTLYING AND INLYING CAROTID SHUNT (WITH AND WITHOUT T-PORT)	2005-05-27
K093847	Thermopeutix, Inc.	DUFLO CATHETER (HEPARIN COATED)	2010-08-25
K151126	Colibri Technologies, Inc.	Foresight Intracardiac Echocardiography (ICE) System	2015-12-18
K931629	Carapace, Inc.	CARAPACE ANGIOGRAPHY TRAYS	1993-12-06
K823758	Access Devices, Inc.	CENTRAL VEIN CATHERIZATION KIT	1983-02-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter
Z-0011-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 8F PRE-SHAPED 40 90CM, Catalog number H965100440, cardiac guide catheter
Z-0012-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F 90CM MULTI PURPOSE, Catalog number H965100460, cardiac guide catheter
Z-0013-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F 90CM MULTI PURPOSE, Catalog number H965100470, cardiac guide catheter

Similar Registrations

Registration Number	Establishment Name	Location
9681260	Boston Scientific Limited	GALWAY, IE
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3012279212	PRYTIME MEDICAL DEVICES, INC.	Lakewood, CO, US
3015550451	MICRO THERAPEUTICS, INC. DBA EV3 NEUROVASCULAR	Irvine, CA, US
3032916632	BECTON, DICKINSON AND COMPANY	Irvine, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9616684. Last updated year: 2026. Please use registration number 9616684 when referencing this establishment in official correspondence.