AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
FDA 510(k) clearance K941981 · decided 1994-07-20
Clearance details
- K-number
- K941981
- Device name
- AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent - Subject to Tracking & PMS
- Date received
- 1994-04-14
- Decision date
- 1994-07-20
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Flagstaff, AZ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Fusion Bioline Vascular Graft (K252445) | Maquet Cardiovascular, LLC | 2026-04-27 |
| Spiral Laminar Flow™ Vascular Arteriovenous Graft (AV0645) (K252277) | Vascular Flow Technologies Limited | 2025-10-20 |
| Gelweave™ Vascular Prostheses (K241550) | Vascutek, Ltd. | 2025-02-27 |
| Gelsoft™ Plus Vascular Prostheses (K241070) | Vascutek, Ltd. | 2024-11-15 |
| Advanta VXT Vascular Graft, Flixene Vascular Graft (K231972) | Atrium Medical Corporation | 2024-03-28 |
| GORE® PROPATEN® Vascular Graft (K240083) | W. L. Gore & Associates, Inc. | 2024-03-01 |
| exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts (K233783) | Peca Labs, Inc. | 2024-01-17 |
| 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 |
| HeRO Graft (K213845) | Merit Medical Systems, Inc. | 2022-08-15 |
| exGraft, exGraft Carbon (K221628) | Peca Labs | 2022-08-04 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S119) | W. L. Gore & Associates, Inc. | 2026-08-03 |
| GORE® TAG® Thoracic Branch Endoprosthesis Zone 0/1 (P210032/S026) | W. L. Gore & Associates, Inc. | 2026-07-13 |
| GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis (P020004/S207) | W. L. Gore & Associates, Inc. | 2026-07-08 |
| GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (P230023/S012) | W. L. Gore & Associates, Inc. | 2026-07-01 |
| GORE® EXCLUDER® AAA Endoprosthesis (P020004/S208) | W. L. Gore & Associates, Inc. | 2026-06-23 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S052) | W. L. Gore & Associates, Inc. | 2026-06-16 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S172) | W. L. Gore & Associates, Inc. | 2026-05-26 |
| GORE® VIABAHN® Endoprosthesis, GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S111) | W. L. Gore & Associates, Inc. | 2026-05-26 |