510(k) K951247 ยท DTZ Oxygenator, Cardiopulmonary Bypass
SPIRALGOLD & SPIRALOXY HOLLOW FIBER OXYGENATORS
| Applicant | Baxter Healthcare Corp, Irvine CA, US |
| Decision | Substantially Equivalent, Nov 2, 1995 |
| Received | Mar 20, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951247
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.