510(k) K941225 ยท DTZ Oxygenator, Cardiopulmonary Bypass
UNIVIX GOLD MEMBRANE OXYGENATION MODULE WITH DUROFLO II HEPARIN TREATMENT
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Aug 16, 1994 |
| Received | Mar 14, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941225
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.