Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015138222

FEI Number

3015138222

Entity Name

Gore European Warehouse Support

City/State/Country

Tilburg Noord-Brabant, NL

Establishment Address

Doctor Paul Janssenweg 150, Tilburg Noord-Brabant 5026, NL

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

W. L. GORE & ASSOCIATES, INC. (Owner Number: 9925013)

Owner / Operator Contact Address

1505 North Fourth Street, Flagstaff, AZ 86004, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K172567

PMA Number

N/A

All Registered Proprietary Names

GORE TIPS Set SutureTOOL system GORE DRYSEAL FLEX INTRODUCER SHEATH GORE® Molding and Occlusion Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-07-10
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2025-08-13
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-05-13
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2018-02-08

Official Correspondent

Lisa Wells

US Agent Details

Lisa Wells Business: W. L. GORE & ASSOCIATES, INC. Email: lwells@wlgore.com Phone: (928) 8644219

Related Public Records

Same Entity

W. L. GORE & ASSOCIATES, INC.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013164176	W. L. Gore & Associates, Inc.	Santa Clara, CA, US
3007284313	W. L. GORE & ASSOCIATES, INC.	Phoenix, AZ, US
2017233	W. L. GORE & ASSOCIATES, INC	FLAGSTAFF, AZ, US
3003910212	W. L. GORE & ASSOCIATES, INC.	ELKTON, MD, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K101883	St Jude Medical	6F ENGAGE/ENGAGE TR INTRODUCER	2010-09-07
K034025	Nmt Medical, Inc.	NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC	2004-03-26
K122854	Arrow International (Subsidiary of Teleflex Inc.)	ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER	2013-01-04
K233691	Acutus Medical, Inc.	FlexCath Cross Transseptal Solution	2023-12-17
K915078	North American Instrument Corp.	MORSE HEMOSTATIC CATHETER INTRODUCER SET	1992-06-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0783-2020	Abbott Medical	2	Fast-Cath Trio HEMOSTASIS INTRODUCER, 14F, 4.6 mm, REF 406303
Z-0789-2020	Abbott Medical	2	Fast-Cath Hemostasis Introducer, HEMOSTASIS INTRODUCER, 8.5F, 2.83 mm, REF 406143 - Product Usage: The Fast-Cath Hemostasis Introducers are indicated for the introduction of angiographic catheters, closed-end catheters, balloon catheters, and electrodes into a vessel where minimizing blood loss is essential.
Z-0013-2009	Edwards Lifesciences, LLC	2	Edwards Lifesciences*Fogarty Fortis*Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.

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3013764800	B. BRAUN MEDICAL INC.	Allentown, PA, US
2020394	BARD PERIPHERAL VASCULAR, INC.	TEMPE, AZ, US
3016904853	SAINT JONES MANAGEMENT LP EOOD	Sofia Sofia-Grad, BG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015138222. Last updated year: 2026. Please use registration number 3015138222 when referencing this establishment in official correspondence.