510(k) K880052 ยท DTJ Holder, Heart-Valve, Prosthesis
EDWARDS-DUROMEDICS MITRAL VALVE ROTATOR
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Apr 1, 1988 |
| Received | Jan 6, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880052
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.