Data / Medical devices / United States / W. L. Gore & Associates, Inc.
W. L. Gore & Associates, Inc.: FDA-registered device maker in Phoenix, AZ, United States, 11 510(k) clearances and 4 PMA approvals
W. L. Gore & Associates, Inc. is registered with the FDA (registration 3007284313) in Phoenix, AZ, United States. It lists 8 device types. The FDA files 11 510(k) clearances and 4 PMA approvals under its listings, the newest dated December 19, 2025. 3 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007284313
- Address
- 32360 N. North Valley Parkway, Phoenix, AZ, United States, 85085
- Owner or operator
- W. L. GORE & ASSOCIATES, INC. (9925013)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- December 18, 2007
- Registered through
- 2027
- Brand names listed
- GORE TIPS Set, GORE-TEX® Cardiovascular Patch, GORE® Acuseal Cardiovascular Patch, GORE® DrySeal Flex Introducer Sheath, GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Conformable AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis, GORE® GUIDRA Steerable Sheath and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Intravascular Occluding, Temporary | MJN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Catheter, Percutaneous | DQY | 2 | Manufacturer | accessdata.fda.gov |
| Dura Substitute | GXQ | 2 | Manufacturer | accessdata.fda.gov |
| Introducer, Catheter | DYB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
| QTL | QTL | Manufacturer | accessdata.fda.gov | |
| Shunt, Portosystemic, Endoprosthesis | MIR | 3 | Manufacturer | accessdata.fda.gov |
| System, Endovascular Graft, Aortic Aneurysm Treatment | MIH | 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 |
|---|---|---|---|---|---|---|
| June 2, 2025 | K250410 | GORE® Tri-Lobe Balloon Catheter | DQY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| October 5, 2018 | K180919 | GORE Tri-Lumen Catheter | DQY | Substantially Equivalent | W. L. Gore and Associates, Inc. | accessdata.fda.gov |
| January 31, 2018 | K172567 | GORE Molding and Occlusion Balloon Catheter | MJN | Substantially Equivalent | W. L. Gore and Associates, Inc. | accessdata.fda.gov |
| July 21, 2016 | K152913 | GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle | DYB | Substantially Equivalent | Creganna Medical Aslo Business AS Cregganna Tactx Medical | accessdata.fda.gov |
| May 12, 2016 | K160254 | GORE DrySeal Flex Introducer Sheath | DYB | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| April 17, 2014 | K140406 | DESTINO TWIST, STEERABLE GUIDING SHEATH | DYB | Substantially Equivalent | Oscor, Inc. | accessdata.fda.gov |
| October 3, 2008 | K081799 | GORE TRI-LOBE BALLOON CATHETER | DQY | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| September 20, 2001 | K012098 | PRECLUDE PERICARDIAL MEMBRANE | DXZ | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| April 8, 1999 | K984526 | ACUSEAL CARDIOVASCULAR PATCH | DXZ | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| November 1, 1995 | K953969 | PRECLUDE DURA SUBSTITUTE | GXQ | Substantially Equivalent | W. L. Gore & Associates, Inc. | accessdata.fda.gov |
| October 11, 1991 | K912107 | GORE-TEX EXPANDED POLY. CARD. PATCH 0.6 AND 0.4MM | DXZ | Substantially Equivalent | W. L. Gore & Associates, 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 |
|---|---|---|---|---|---|---|
| December 19, 2025 | P250017 | GORE® VIABAHN® FORTEGRA Venous Stent | QTL | 3 | April 30, 2026 | accessdata.fda.gov |
| December 22, 2020 | P200030 | Gore Excluder Conformable AAA Endoprosthesis (CEXC) | MIH | 26 | July 29, 2026 | accessdata.fda.gov |
| December 6, 2004 | P040027 | GORE VIATORR TIPS | MIR | 94 | October 27, 2025 | accessdata.fda.gov |
| November 6, 2002 | P020004 | EXCLUDER BIFURCATED ENDOPROSTHESIS | MIH | 199 | July 8, 2026 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 12, 2021 | 88331 | Class II | Ongoing | Gore Molding & Occlusion Balloon Catheter, REF Catalogue Number MOB37, SN XXXXXXXX, 10 mm - 37 m 10 Fr, Guidewire Compatibility 0.035", STERILE EO, CE2797, UDI: (00)733132639489 | Complaints received concerning Balloon Catheter leakage from the guidewire lumen and the y-hub during preparation resulting in either insufficient inflation or an inability to inflate. | accessdata.fda.gov |
| January 6, 2020 | 84533 | Class II | Terminated | GORE EXCLUDER AAA Endoprosthesis | Firm has received reports of leading end catheter component separations. | accessdata.fda.gov |
| November 18, 2019 | 85379 | Class II | Terminated | Gore DrySeal Flex Introducer Sheath, Catalog #DSF1433, 33cm 14FR, Sterile. The responsible firm on the label is W. L. Gore & Associates, Inc., Flagstaff, AZ. | The devices were mislabeled with the incorrect product size resulting in 16Fr devices being labeled as 14Fr devices. | accessdata.fda.gov |
Compare with other makers
- All makers of Introducer, Catheter
- All makers of Catheter, Percutaneous
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- All makers of Dura Substitute
- All makers of Shunt, Portosystemic, Endoprosthesis
- All makers of Catheter, Intravascular Occluding, Temporary
Updated April 30, 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.