510(k) K974648 ยท MOP Rotator, Prosthetic Heart Valve
SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
| Applicant | Sulzer Carbomedics, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Aug 4, 1998 |
| Received | Dec 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974648
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.