PROPATCH SOFT TISSUE REPAIR MATRIX
FDA 510(k) clearance K061892 · decided 2006-11-22
Clearance details
- K-number
- K061892
- Device name
- PROPATCH SOFT TISSUE REPAIR MATRIX
- Applicant
- Cryolife, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-03
- Decision date
- 2006-11-22
- Days to decision
- 142 days
- Clearance type
- Abbreviated
- Product code
- FTM
- Device class
- 2
- Regulation number
- 878.3300
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Kennesaw, GA, US
- Third-party review
- No
- Expedited review
- No
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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 |