510(k) K961000 ยท DTZ Oxygenator, Cardiopulmonary Bypass
CAPIOX SX18 HOLLOW FIBER OXYGENATOR WITH AND WITHOUT DETACHABLE HARDSHELL RESERVOIR
| Applicant | Terumo Medical Corp., Elkton MD, US |
| Decision | Substantially Equivalent, Oct 2, 1996 |
| Received | Mar 12, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961000
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.