510(k) K252059 ยท OHA Heart Valve, More Than Minimally Manipulated Allograft
CryoValve SG Pulmonary Valve (SGPV10) CryoValve SG Pulmonary Valve and Conduit (SGPV00)
| Applicant | Artivion, Inc., Kennesaw GA, US |
| Decision | Substantially Equivalent, Oct 2, 2025 |
| Received | Jul 1, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K252059
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.