Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3002124543

FEI Number

3002124543

Entity Name

BIOCOMPATIBLES U.K. LIMITED, a BTG Company

City/State/Country

Farnham, SURREY ENGLAND, GB

Establishment Address

Chapman House, Weydon Lane, Farnham Business Park, Farnham, SURREY ENGLAND GU9 8QL, GB

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

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

N/A

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
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2019-10-10
HCG	Device, Neurovascular Embolization	Neurology	Class 2	882.5950	2019-10-10
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2019-10-10
OEZ	Cardiovascular Procedure Kit	Cardiovascular	Class 2	870.1200	2023-11-15
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	1998-06-11
KPY	Shield, Protective, Personnel	Radiology	Class 1	892.6500	2024-09-16

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
K951256	Target Therapeutics	DETACHABLE PLATINUM COIL (GUGLIELMI DETACHABLE COIL, GDC)	1995-09-08

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

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9616684	Boston Scientific Limited	CORK Munster, IE
3002807295	IONISOS	SABLE-SUR-SARTHE, FR
1225687	Boston Scientific Corp., Marina Bay Cust. Fulfillment Center	QUINCY, MA, US
2124215	Boston Scientific Corporation	Saint Paul, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002124543. Last updated year: 2026. Please use registration number 3002124543 when referencing this establishment in official correspondence.