Data / Medical devices / Netherlands / Boston Scientific International BV, European Dist. Ctr.

Boston Scientific International BV, European Dist. Ctr.: FDA-registered device maker in KERKRADE Limburg, Netherlands, 2 510(k) clearances and 4 PMA approvals

Name: Boston Scientific International BV, European Dist. Ctr. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Boston Scientific International BV, European Dist. Ctr. is registered with the FDA (registration 3005111382) in KERKRADE Limburg, Netherlands. It lists 9 device types. The FDA files 2 510(k) clearances and 4 PMA approvals under its listings, the newest dated October 30, 2020. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3005111382
Address: Verstastraat 6, KERKRADE Limburg, Netherlands, 6468 EX
Owner or operator: Boston Scientific Corporation (9912058)
Roles: Manufacturer
First device listed: January 22, 2008
Registered through: 2026
Brand names listed: Ranger Paclitaxel-Coated PTA Balloon Catheter, VENOUS WALLSTENT Self-Expanding Stent, WALLSTENT Endoprosthesis Self-Expanding Stent, WALLSTENT RP Endoprosthesis Self-Expanding Stent

Devices it lists

Device	Product code	Class	Role	Source
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
Device, Vascular, For Promoting Embolization	KRD	2	Manufacturer	accessdata.fda.gov
Drug-Eluting Peripheral Transluminal Angioplasty Catheter	ONU	3	Manufacturer	accessdata.fda.gov
Shunt, Portosystemic, Endoprosthesis	MIR	3	Manufacturer	accessdata.fda.gov
Stent, Central Venous	QKJ	3	Manufacturer	accessdata.fda.gov
Stent, Coronary	MAF	3	Manufacturer	accessdata.fda.gov
Stent, Iliac	NIO	3	Manufacturer	accessdata.fda.gov
Stent, Iliac Vein	QAN	3	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 19, 2018	K180102	Embozene Color-Advanced Microspheres	NOY	Substantially Equivalent	Boston Scientific	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

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
October 30, 2020	P190019	Ranger Paclitaxel-Coated PTA Balloon Catheter	ONU	41	August 4, 2026	accessdata.fda.gov
November 16, 2001	P980033	WALLSTENT ENDOPROSTHESIS	QKJ	65	May 6, 2026	accessdata.fda.gov
May 28, 1996	P940019	WALLSTENT(R) ILIAC ENDOPROSTHESIS	NIO	63	May 6, 2026	accessdata.fda.gov
September 29, 1995	P930031	WALLSTENT(R) TIPS ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM	MIR	72	June 27, 2024	accessdata.fda.gov

Compare with other makers

Updated August 4, 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.