510(k) K863476 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SCIMED MEMBRANE OXYGENATOR SYSTEM - ECMO
| Applicant | Scimed Life Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Nov 25, 1986 |
| Received | Sep 9, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863476
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.