510(k) K931444 ยท DTZ Oxygenator, Cardiopulmonary Bypass
PLEXUS 2 & 3.5 HOLLOW FIBER OXYGENATORS
| Applicant | Sorin Biomedica, Fiat, USA, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, May 27, 1994 |
| Received | Mar 22, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K931444
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.