510(k) K884560 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
| Applicant | Scimed Life Systems, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Apr 3, 1989 |
| Received | Oct 31, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K884560
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.