510(k) K901249 ยท DTZ Oxygenator, Cardiopulmonary Bypass
PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 11, 1990 |
| Received | Mar 16, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901249
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.