510(k) K871596 ยท DTJ Holder, Heart-Valve, Prosthesis
IONESCU-SHILEY PERICARDIAL XENOGRAFT (ISU)
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 15, 1987 |
| Received | Apr 24, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K871596
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.