510(k) K881449 ยท LXN Probe, Test, Heart-Valve
EDWARDS-DUROMEDICS LEAFLET PROBE, MODEL 1116
| Applicant | Baxter Healthcare Corp, Santa Ana CA, US |
| Decision | Substantially Equivalent, Jun 15, 1988 |
| Received | Apr 5, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881449
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.