GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
FDA premarket approval P130006 · decided 2013-12-05
Approval details
- PMA number
- P130006
- Trade name
- GORE VIABAHN ENDOPROSTHESIS AND ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE
- Generic name
- System, endovascular graft, arteriovenous (AV) dialysis access circuit stenosis treatment
- Applicant
- W. L. Gore & Associates, Inc.
- Date received
- 2013-04-01
- Decision date
- 2013-12-05
- Days to decision
- 248 days
- Decision code
- APPR
- Product code
- PFV
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Flagstaff, AZ
- Statement
- APPROVAL FOR THE GORE VIABAHN ENDOPROSTHESIS AND THE GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF STENOSIS OR THROMBOTIC OCCLUSION AT THE VENOUS ANASTOMOSIS OF SYNTHETIC ARTERIOVENOUS (AV) ACCESS GRAFTS.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® Tri-Lobe Balloon Catheter (K250410) | W. L. Gore & Associates, Inc. | 2025-06-02 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| GORE® PROPATEN® Vascular Graft (K232312) | W. L. Gore & Associates, Inc. | 2024-01-09 |
| GORE® ACUSEAL Vascular Graft (K233551) | W. L. Gore & Associates, Inc. | 2023-12-19 |
| GORE® ACUSEAL Vascular Graft (K231505) | W. L. Gore & Associates, Inc. | 2023-06-23 |
| GORE BIO-A Tissue Reinforcement (K191773) | W. L. Gore & Associates, Inc. | 2019-07-31 |
| GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement (K181940) | W. L. Gore & Associates, Inc. | 2018-08-17 |
| GORE ENFORM Biomaterial (K173333) | W. L. Gore & Associates, Inc. | 2018-04-05 |