Product code OHA ยท Class U
Heart Valve, More Than Minimally Manipulated Allograft
0510(k)s in 12 months (4 all time)
0recalls in 12 months (4 all time)
4recalls that name a 510(k)
Top companies in OHA
| Company | 510(k)s | Recalls |
|---|---|---|
| Cryolife, Inc. | 3 | 2 |
| Artivion, Inc. | 1 | 2 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 2, 2025 | K252059 | CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00) Artivion, Inc. | OHA |
| May 25, 2010 | K092021 | CRYOVALVE SG PULMONARY HUMAN HEART VALVE (AND CONDUIT) Cryolife, Inc. | OHA |
| Feb 6, 2009 | K083106 | CRYOVALVE SG PULMONARY VALVE AND CONDUIT Cryolife, Inc. | OHA |
| Feb 7, 2008 | K033484 | HUMAN HEART VALVE, CRYOVALVE SG Cryolife, Inc. | OHA |
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