CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
FDA 510(k) clearance K252059 · decided 2025-10-02
Clearance details
- K-number
- K252059
- Device name
- CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
- Applicant
- Artivion, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-07-01
- Decision date
- 2025-10-02
- Days to decision
- 93 days
- Clearance type
- Special
- 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 HUMAN HEART VALVE (AND CONDUIT) (K092021) | Cryolife, Inc. | 2010-05-25 |
| 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
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| AMDS Hybrid Prosthesis (P250055) | Artivion, Inc. | 2026-06-26 |