510(k) K910107 ยท DTZ Oxygenator, Cardiopulmonary Bypass
DURAFLO II HEPARIN OXYGENATOR MODEL UNIVOX GOLD
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Apr 10, 1991 |
| Received | Jan 10, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K910107
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.