Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005111382

FEI Number

3005111382

Entity Name

Boston Scientific International BV, European Dist. Ctr.

City/State/Country

KERKRADE Limburg, NL

Establishment Address

VERSTASTRAAT 6, KERKRADE Limburg 6468 EX, NL

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

N/A

PMA Number

P190019

All Registered Proprietary Names

WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT RP Endoprosthesis Self-Expanding Stent WALLSTENT Endoprosthesis Self-Expanding Stent Ranger Paclitaxel-Coated PTA Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NIO	Stent, Iliac	Unknown	Class 3	N/A	2008-01-22
MAF	Stent, Coronary	Unknown	Class 3	N/A	2008-01-22
MIR	Shunt, Portosystemic, Endoprosthesis	Unknown	Class 3	N/A	2008-01-22
MIR	Shunt, Portosystemic, Endoprosthesis	Unknown	Class 3	N/A	2008-01-22
KRD	Device, Vascular, For Promoting Embolization	Cardiovascular	Class 2	870.3300	2018-04-25
NAJ	Agents, Embolic, For Treatment Of Uterine Fibroids	Cardiovascular	Class 2	870.3300	2018-04-25
NOY	Agents, Embolic, For Treatment Of Benign Prostatic Hyperplasia	Gastroenterology, Urology	Class 2	876.5550	2018-04-25
ONU	Drug-Eluting Peripheral Transluminal Angioplasty Catheter	Unknown	Class 3	N/A	2020-11-02

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 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

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2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
2124215	Boston Scientific Corporation	Saint Paul, MN, US
1000121056	Boston Scientific Corporation	Coventry, RI, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005111382. Last updated year: 2026. Please use registration number 3005111382 when referencing this establishment in official correspondence.