Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007284313

FEI Number

3007284313

Entity Name

W. L. GORE & ASSOCIATES, INC.

City/State/Country

Phoenix, AZ, US

Establishment Address

32360 N. North Valley Parkway, Phoenix, AZ 85085, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical 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

K250410

PMA Number

N/A

All Registered Proprietary Names

GORE® VIABAHN® FORTEGRA Venous Stent GORE® Tri-Lumen Catheter GORE® VIATORR® TIPS Endoprosthesis GORE PRECLUDE pericardial membrane Acuseal Cardiovascular Patch GORE-TEX Cardiovascular Patch GORE® Molding and Occlusion Balloon Catheter GORE DRYSEAL FLEX INTRODUCER SHEATH GORE® PRECLUDE® Dura Substitute GORE TIPS Set GORE® EXCLUDER® Conformable AAA Endoprosthesis (CEXC) GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® Tri-Lobe Balloon Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QTL	N/A	N/A	Class N/A	N/A	2026-01-06
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2018-10-23
MIR	Shunt, Portosystemic, Endoprosthesis	Unknown	Class 3	N/A	2007-12-19
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2007-12-18
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2007-12-18
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2007-12-19
MJN	Catheter, Intravascular Occluding, Temporary	Cardiovascular	Class 2	870.4450	2018-02-08
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2016-05-13
GXQ	Dura Substitute	Neurology	Class 2	882.5910	2007-12-19
DYB	Introducer, Catheter	Cardiovascular	Class 2	870.1340	2024-07-10
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2021-01-11
MIH	System, Endovascular Graft, Aortic Aneurysm Treatment	Unknown	Class 3	N/A	2007-12-18
DQY	Catheter, Percutaneous	Cardiovascular	Class 2	870.1250	2025-06-09

Official Correspondent

Lisa Wells

US Agent Details

No US Agent registered (Local establishment).

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
2017233	W. L. GORE & ASSOCIATES, INC	FLAGSTAFF, AZ, US
3015138222	Gore European Warehouse Support	Tilburg Noord-Brabant, NL
3003910212	W. L. GORE & ASSOCIATES, INC.	ELKTON, MD, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K043580	Chestnut Medical Technologies, Inc.	ALLIGATOR RETRIEVAL DEVICE (ARD)	2005-03-24
K982883	Medtronics Interventional Vascular	MEDTRONIC 7F AND 8F ZUMA GUIDING CATHETER	1998-09-04
K132420	Reflow Medical	WINGMAN EXTENDABLE TIP SUPPORT CATHETER	2013-09-19
K082339	Endocross, Ltd.	ENABLER-P SUPPORT CATHETER	2008-11-20
K210009	CenterPoint Systems, LLC	Guiding Catheter	2021-11-24

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2010	Penumbra Inc.	2	Penumbra Neuron Delivery Catheter 070, percutaneous catheter, catalog numbers PND6F0701058, PND6F070956, PND6F0701058M, and PND6F070956M; manufactured by Penumbra, Inc., Alameda, CA. Indicated for the introduction of interventional devices into the peripheral, coronary, and neuro vasculature.
Z-0003-2014	Cordis Corporation	2	Cordis ADROIT 6F Guiding Catheter Product Usage: For intravascular introduction of interventional and/or diagnostic devices into the coronary or peripheral vascular system.
Z-0009-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 6F PRE-SHAPED 40 90CM, Catalog number H965100420, cardiac guide catheter
Z-0010-04	Bard Peripheral Vascular	2	Conquest Balloon Dilation Catheters Model/Catalog Number CQ 75124
Z-0010-2024	Boston Scientific Corporation	2	Guider Softip Guide Catheter 7F PRE-SHAPED 40 90CM, Catalog number H965100430, cardiac guide catheter

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007284313. Last updated year: 2026. Please use registration number 3007284313 when referencing this establishment in official correspondence.