510(k) K964043 ยท DTZ Oxygenator, Cardiopulmonary Bypass
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Sep 29, 1997 |
| Received | Oct 9, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964043
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.