510(k) K881279 ยท DTI Sizer, Heart-Valve, Prosthesis
EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, May 18, 1988 |
| Received | Mar 22, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881279
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.