510(k) K894630 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Oct 20, 1989 |
| Received | Jul 24, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K894630
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.