510(k) K083106 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
CRYOVALVE SG PULMONARY VALVE AND CONDUIT
| Applicant | Cryolife, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Feb 6, 2009 |
| Received | Oct 20, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 11, 2011 | CryoLife, Inc. Pulmonary Valve & Conduit SG
Used in heart surgery Terminated |
MIE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.