W. L. GORE & ASSOCIATES, INC

FDA Device Registration & Listing · FLAGSTAFF, AZ, US · Registration 2017233

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2017233
FEI Number
2017233
Entity Name
W. L. GORE & ASSOCIATES, INC
City/State/Country
FLAGSTAFF, AZ, US
Establishment Address
1505 NORTH FOURTH ST., FLAGSTAFF, AZ 86004, US
Establishment Type(s)
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
Y
Expiration Date (Year)
2026
510(k) Number
K013250
PMA Number
N/A

All Registered Proprietary Names

GORE® CARDIOFORM Septal Occluder, GORE® CARDIOFORM ASD Occluder GORE® ACUSEAL Vascular Graft EPTFE Ringed Gore-Tex VG FEP Ringed Gore-Tex Stretch VG GORE® TAG® Thoracic Branch Endoprosthesis GORE® PROPATEN® Vascular Graft GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE) GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface Gore-Tex Vascular Graft GORE® EXCLUDER® AAA Endoprosthesis GORE® EXCLUDER® Iliac Branch Endoprosthesis GORE® VIATORR® TIPS Endoprosthesis GORE-TEX Vascular Graft GORE-TEX® STRETCH Vascular Graft GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface GORE TAG Conformable Endoprosthesis/GORE TAG Conformable Endoprosthesis with Active Control GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis Custom Device GO Gore-Tex Vascular Graft GORE® Tri-Lumen Catheter GORE-TEX Vascular Graft Gore-Tex Vascular Graft; Stretch

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MLV Transcatheter Septal Occluder Unknown Class 3 N/A 2006-02-07
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Cardiovascular Class 2 870.3450 2024-02-02
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2024-02-02
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-18
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-19
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2022-05-26
SDZ Endovascular System For Treatment Of Ascending Aorta And Aortic Arch Lesions Unknown Class 3 N/A 2022-05-26
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2024-03-19
QZK Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions Unknown Class 3 N/A 2024-02-29
PFV System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment Unknown Class 3 N/A 2014-06-23
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-19
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2007-12-18
MIR Shunt, Portosystemic, Endoprosthesis Unknown Class 3 N/A 2007-12-19
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Cardiovascular Class 2 870.3450 2007-12-19
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-19
NIP Stent, Superficial Femoral Artery Unknown Class 3 N/A 2005-08-16
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2007-12-19
PRL Iliac Covered Stent, Arterial Unknown Class 3 N/A 2017-01-27
QZK Endovascular System For Treatment Of Thoracoabdominal And Pararenal Aortic Lesions Unknown Class 3 N/A 2017-01-27
MIH System, Endovascular Graft, Aortic Aneurysm Treatment Unknown Class 3 N/A 2025-07-07
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-19
DQY Catheter, Percutaneous Cardiovascular Class 2 870.1250 2018-10-23
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-19
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2007-12-18

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
3007284313 W. L. GORE & ASSOCIATES, INC. Phoenix, 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
K962639 Impra, Inc. IMPRA CARBOFLO EPTFE VASCULAR GRAFT 1996-10-03
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2026 W L Gore & Associates, Inc. 2
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.
Z-0006-2019 N/A 3
ENDOLOGIX AFX Endovascular AAA System, Stent Graft System, Rx Only, Sterile EO, REF: BA22-120/I20-40, BA22-100/I20-40, BA22-80/I20-40, BA22-60/I20-40, BA22-40/I20-40, BA22-120/I16-40, BA22-100/I16-40, BA22-80/I16-40, BA22-60/I16-40, BA22-40/I16-40, BA22-120/I13-40, BA22-100/I13-40, BA22-80/I13-40, BA22-60/I13-40, BA22-40/I13-40, BA22-110/I20-30, BA22-90/I20-30, BA22-70/I20-30, BA22-50/I20-30, BA22-110/I16-30, BA22-90/I16-30, BA22-70/I16-30, BA22-50/I16-30, BA22-100/I20-55, BA22-80/I20-55, BA22-100/I16-55, BA22-80/I16-55, BA25-120/I20-40, BA25-100/I20-40, BA25-80/I20-40, BA25-60/I20-40, BA25-40/I20-40, BA25-120/I16-40, BA25-100/I16-40, BA25-80/I16-40, BA25-60/I16-40, BA25-40/I16-40, BA25-120/I13-40, BA25-100/I13-40, BA25-80/I13-40, BA25-60/I13-40, BA25-40/I13-40, BA25-110/I20-30, BA25-90/I20-30, BA25-70/I20-30, BA25-50/I20-30, BA25-110/I16-30, BA25-90/I16-30, BA25-70/I16-30, BA25-50/I16-30, BA25-100/I20-55, BA25-80/I20-55, BA25-100/I16-55, BA25-80/I16-55, BA28-120/I20-40, BA28-100/I20-40, BA28-80/I20-40, BA28-60/I20-40, BA28-40/I20-40, BA28-120/I16-40, BA28-100/I16-40, BA28-80/I16-40, BA28-60/I16-40, BA28-40/I16-40, BA28-120/I13-40, BA28-100/I13-40, BA28-80/I13-40, BA28-60/I13-40, BA28-40/I13-40, BA28-110/I20-30, BA28-90/I20-30, BA28-70/I20-30, BA28-50/I20-30, BA28-110/I16-30, BA28-90/I16-30, BA28-70/I16-30, BA28-50/I16-30, BA28-100/I20-55, BA28-80/I20-55, BA28-100/I16-55, BA28-80/I16-55
Z-0007-2019 N/A 3
ENDOLOGIX AFX2 Bifurcated Endograft System, Stent Graft System, Rx Only, Sterile EO, REF: BEA22-120/I20-40, BEA22-100/I20-40, BEA22-80/I20-40, BEA22-60/I20-40, BEA22-40/I20-40, BEA22-120/I16-40, BEA22-100/I16-40, BEA22-80/I16-40, BEA22-60/I16-40, BEA22-40/I16-40, BEA22-120/I13-40, BEA22-100/I13-40, BEA22-80/I13-40, BEA22-60/I13-40, BEA22-40/I13-40, BEA22-110/I20-30, BEA22-90/I20-30, BEA22-70/I20-30, BEA22-50/I20-30, BEA22-110/I16-30, BEA22-90/I16-30, BEA22-70/I16-30, BEA22-50/I16-30, BEA22-100/I20-55, BEA22-80/I20-55, BEA22-100/I16-55, BEA22-80/I16-55, BEA25-120/I20-40, BEA25-100/I20-40, BEA25-80/I20-40, BEA25-60/I20-40, BEA25-40/I20-40, BEA25-120/I16-40, BEA25-100/I16-40, BEA25-80/I16-40, BEA25-60/I16-40, BEA25-40/I16-40, BEA25-120/I13-40, BEA25-100/I13-40, BEA25-80/I13-40, BEA25-60/I13-40, BEA25-40/I13-40, BEA25-110/I20-30, BEA25-90/I20-30, BEA25-70/I20-30, BEA25-50/I20-30, BEA25-110/I16-30, BEA25-90/I16-30, BEA25-70/I16-30, BEA25-50/I16-30, BEA25-100/I20-55, BEA25-80/I20-55, BEA25-100/I16-55, BEA25-80/I16-55, BEA28-120/I20-40, BEA28-100/I20-40, BEA28-80/I20-40, BEA28-60/I20-40, BEA28-40/I20-40, BEA28-120/I16-40, BEA28-100/I16-40, BEA28-80/I16-40, BEA28-60/I16-40, BEA28-40/I16-40, BEA28-120/I13-40, BEA28-100/I13-40, BEA28-80/I13-40, BEA28-60/I13-40, BEA28-40/I13-40, BEA28-110/I20-30, BEA28-90/I20-30, BEA28-70/I20-30, BEA28-50/I20-30, BEA28-110/I16-30, BEA28-90/I16-30, BEA28-70/I16-30, BEA28-50/I16-30, BEA28-100/I20-55, BEA28-80/I20-55, BEA28-100/I16-55, BEA28-80/I16-55
Z-0008-2019 N/A 3
ENDOLOGIX AFX/AFX2, Proximal (Aortic) Extension Endograft, Rx Only, Sterile EO, AFX Proximal Accessory, Infrarenal Model #/REF: A22-22/C55, A22-22/C75, A22-22/C95, A25-25/C55, A25-25/C75, A25-25/C95, A28-28/C55, A28-28/C75, A28-28/C95, A31-31/C80, A31-31/C100, A34-34/C80, A34-34/C100; Suprarenal Model #/REF: A22-22/C55-O20, A22-22/C75-O20, A22-22/C95-O20, A25-25/C55-O20, A25-25/C75-O20, A25-25/C95-O20, A28-28/C55-O20, A28-28/C75-O20, A28-28/C95-O20, A31-31/C80-O20, A31-31/C100-O20, A34-34/C80-O20, A34-34/C100-O20; AFX Vela, Infrarenal Model #/REF: A22-22/C55V, A22-22/C75V, A22-22/C95V, A25-25/C55V, A25-25/C75V, A25-25/C95V, A28-28/C55V, A28-28/C75V, A28-28/C95V, A31-31/C80V, A31-31/C100V, A34-34/C80V, A34-34/C100V; Suprarenal Model #/REF: A22-22/C55-O20V, A22-22/C75-O20V, A22-22/C95-O20V, A25-25/C55-O20V, A25-25/C75-O20V, A25-25/C95-O20V, A28-28/C55-O20V, A28-28/C75-O20V, A28-28/C95-O20V, A31-31/C80-O20V, A31-31/C100-O20V, A34-34/C80-O20V, A34-34/C100-O20V
Z-0009-2019 N/A 3
ENDOLOGIX AFX/AFX2, Limb (Iliac) Extension Endograft, Rx Only, Sterile EO, AFX Limb Accessory Model #/REF: I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F, I16-16/C55, I16-16/C55F, I16-16/C88, I20-13/C70F, I20-13/C88F; AFX Stand Alone I16-16/C55 SA, I16-16/C55F SA, I16-16/C88 SA, I20-13/C70F SA, I20-13/C88F SA, I20-20/C55 SA, I20-20/C55F SA, IS20-25/C55 SA, IF20-25/C65 SA, IS20-25/C65 SA

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2017233. Last updated year: 2026. Please use registration number 2017233 when referencing this establishment in official correspondence.
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