510(k) K864155 ยท DTJ Holder, Heart-Valve, Prosthesis
MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS
| Applicant | American Edwards Laboratories, Santa Ana CA, US |
| Decision | Substantially Equivalent, Nov 20, 1986 |
| Received | Oct 23, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K864155
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.