CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
FDA 510(k) clearance K092021 · decided 2010-05-25
Clearance details
- K-number
- K092021
- Device name
- CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT)
- Applicant
- Cryolife, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-06
- Decision date
- 2010-05-25
- Days to decision
- 323 days
- Clearance type
- Traditional
- Product code
- OHA
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Kennesaw, GA, 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 |
|---|---|---|
| CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (K252059) | Artivion, Inc. | 2025-10-02 |
| CRYOVALVE SG PULMONARY VALVE AND CONDUIT (K083106) | Cryolife, Inc. | 2009-02-06 |
| HUMAN HEART VALVE, CRYOVALVE SG (K033484) | Cryolife, Inc. | 2008-02-07 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| CryoValve SG Pulmonary Human Heart Valve, SGPV00, Cryopreserved Decellularized Heart Valve recall (Z-2531-2024) | Artivion, Inc | 2024-08-08 |
| CryoValve SG Cryopreserved Pulmonary Human Heart Valve recall (Z-1545-2024) | Artivion, Inc | 2024-04-16 |
| Pulmonary Valve & Conduit SG Used in heart surgery recall (Z-1560-2011) | CryoLife, Inc. | 2011-03-04 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BioGlue® Surgical Adhesive (P010003/S043) | Cryolife, Inc. | 2026-07-15 |
| 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 |