510(k) K901624 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jul 3, 1990 |
| Received | Apr 9, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K901624
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.