510(k) K862918 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SCIMED II-SM25 MEMBRANE OXYGENATOR SYSTEM
| Applicant | Scimed Life Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Sep 23, 1986 |
| Received | Aug 1, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K862918
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.