OHA
4 FDA 510(k) clearances · Product code
FDA profile
- Official device name
- Heart Valve, More Than Minimally Manipulated Allograft
- Device class
- Unclassified
- Medical specialty
- Unknown
- Flags
- Implant
- FDA definition
- For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
- Adverse events (MAUDE)
- 2008: 3 · 2011: 8 · 2014: 10 · 2020: 12
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) (K252059) | Artivion, Inc. | 2025-10-02 |
| 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 |
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Every clearance here is in the API, with alerts when new ones post.