GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
FDA 510(k) clearance K914448 · decided 1991-11-05
Clearance details
- K-number
- K914448
- Device name
- GORE-TEX(R) CARDIOVASCULAR PATCH, PROCESS CHANGE
- Applicant
- W. L. Gore & Associates, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-10-04
- Decision date
- 1991-11-05
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- DXZ
- Device class
- 2
- Regulation number
- 870.3470
- 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 |
|---|---|---|
| PeriBeam® Pericardial Membrane (K240775) | Tamabio | 2025-04-18 |
| Vascutek Gelseal Patch, Vascutek Gelsoft Patch, Vascutek Thin Wall Carotid Patch (K200955) | Vascutek, Ltd. | 2020-07-08 |
| PhotoFix Decellularized Bovine Pericardium (K162506) | Cryolife, Inc. | 2017-03-09 |
| VascuCel (K162579) | Admedus Regen Pty, Ltd. | 2016-10-14 |
| CorMatrix Tyke (K152127) | Cormatrix Cardiovascular, Inc. | 2016-02-04 |
| PremiPatch PTFE Pledget (K151865) | Aesculap, Inc. | 2015-10-27 |
| PERI-GUARD Repair Patch & SUPPLE PERI-GUARD Repair Patch (K142447) | Synovis Life Technologies, Inc. | 2015-01-07 |
| VASCU-GUARD Peripheral Vascular Patch (K142461) | Synovis Life Technologies, Inc. | 2014-11-25 |
| CORMATRIX ECM FOR VASCULAR REPAIR (K140789) | Cormatrix Cardiovascular, Inc. | 2014-07-15 |
| CARDIOCEL (K130872) | Celxcel Pty, Ltd. | 2014-01-30 |
| SYNOVIS COLLAGEN MATRIX (TBD) (K122306) | Synovis Surgical Innovations | 2013-03-08 |
| SMI CARDIOVASCULAR PATCH (K122105) | Solinas Medical, Inc. | 2012-12-07 |
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 |