510(k) K802970 ยท DTZ Oxygenator, Cardiopulmonary Bypass
TERUMO HOLLOW FIBER OXYGENATOR
| Applicant | Terumo America, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 22, 1981 |
| Received | Nov 21, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802970
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.