510(k) K033484 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
HUMAN HEART VALVE, CRYOVALVE SG
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 7, 2008 |
| Received | Nov 4, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033484
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 1, 2008 | CryoLife, Inc. CryoValve, Aortic Valve & Conduit Terminated |
MIE | None listed |
| Sep 1, 2008 | CryoLife, Inc. CryoValve, Pulmonary Valve & Conduit Terminated |
MIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.