GORE-TEX VASCULAR GRAFT
FDA 510(k) clearance K881732 · decided 1988-05-18
Clearance details
- K-number
- K881732
- Device name
- GORE-TEX VASCULAR GRAFT
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-04-22
- Decision date
- 1988-05-18
- Days to decision
- 26 days
- Clearance type
- Traditional
- Product code
- DYF
- 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 |
|---|---|---|
| IMPRA CARBOFLO EPTFE VASCULAR GRAFTS (K004012) | Impra, Inc. | 2001-05-14 |
| ADVANTA SUPER SOFT GRAFT (K000504) | Atrium Medical Corp. | 2000-03-01 |
| ADVANTA GRAFT (<6MM) (K992958) | Atrium Medical Corp. | 1999-10-01 |
| PTFE RINGED GORE-TEX VASCULAR GRAFT (K991683) | W. L. Gore & Associates, Inc. | 1999-09-08 |
| ADVANTA GRAFT (K992441) | Atrium Medical Corp. | 1999-08-20 |
| PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451 (K984183) | Possis Medical, Inc. | 1999-02-01 |
| DISTAFLO BYPASS GRAFT (K983769) | Impra, Inc. | 1998-12-15 |
| VENAFLO PTFE VASCULAR GRAFT, VENAFLO GRAFT WITH CARBON, VENAFLO VASCULAR GRAFT (K981076) | Impra, Inc. | 1998-05-07 |
| IMPRA EPTFE ARTERIOVENOUS CUFFED GRAFT (K964877) | Impra, Inc. | 1997-03-20 |
| MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (K960766) | Meadox Medicals, Div. Boston Scientific Corp. | 1997-03-19 |
| DIASTAT VASCULAR ACCESS GRAFT (K955533) | W. L. Gore & Associates, Inc. | 1996-05-15 |
| DIASTAT VASCULAR ACCESS GRAFT (K953287) | W. L. Gore & Associates, Inc. | 1995-10-06 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GORE® VIABAHN® FORTEGRA Venous Stent (P250017) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® CARDIOFORM Septal Occluder; GORE® CARDIOFORM ASD Occluder (P050006/S116) | W. L. Gore & Associates, Inc. | 2025-12-19 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S048) | W. L. Gore & Associates, Inc. | 2025-11-24 |
| GORE® VIATORR® TIPS Endoprosthesis with Controlled Expansion (P040027/S099) | W. L. Gore & Associates, Inc. | 2025-10-27 |
| GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P130006/S110) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® Endoprosthesis; GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface (P040037/S171) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® TAG® Thoracic Branch Endoprosthesis (P210032/S024) | W. L. Gore & Associates, Inc. | 2025-10-17 |
| GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (P160021/S049) | W. L. Gore & Associates, Inc. | 2025-10-17 |