510(k) K951368 ยท MOP Rotator, Prosthetic Heart Valve
CARBOMEDICS EXENDED MITRAL ROTATOR
| Applicant | Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jun 20, 1995 |
| Received | Mar 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951368
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.