510(k) K880451 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SCIMED MODELS P-7-14 AND A-19-38 HEAT EXCHANGERS
| Applicant | Scimed Life Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Apr 28, 1988 |
| Received | Feb 2, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880451
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.