PhotoFix Decellularized Bovine Pericardium
FDA 510(k) clearance K162506 · decided 2017-03-09
Clearance details
- K-number
- K162506
- Device name
- PhotoFix Decellularized Bovine Pericardium
- Applicant
- Cryolife, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2016-09-08
- Decision date
- 2017-03-09
- Days to decision
- 182 days
- Clearance type
- Traditional
- Product code
- DXZ
- Device class
- 2
- Regulation number
- 870.3470
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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| 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 |
| SMI CARDIOVASCULAR PACH (K112683) | Solimas Medical, Inc. | 2011-12-14 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BioGlue® Surgical Adhesive (P010003/S042) | Cryolife, Inc. | 2025-03-18 |
| BioGlue® Surgical Adhesive (P010003/S041) | Cryolife, Inc. | 2023-10-20 |
| CardioGenesis TMR System (P970029/S040) | Cryolife, Inc. | 2022-09-01 |
| BioGlue Surgical Adhesive (P010003/S040) | Cryolife, Inc. | 2022-05-25 |
| BioGlue® Surgical Adhesive (P010003/S039) | Cryolife, Inc. | 2021-12-09 |
| BioGlue Surgical Adhesive (P010003/S038) | Cryolife, Inc. | 2021-07-23 |
| TMR Holmium Laser System (P970029/S038) | Cryolife, Inc. | 2021-01-21 |
| BioGlue Surgical Adhesive (P010003/S037) | Cryolife, Inc. | 2019-12-20 |