510(k) K974085 ยท DTZ Oxygenator, Cardiopulmonary Bypass
COBE OXYGENATOR PRODUCTS
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Jan 27, 1998 |
| Received | Oct 29, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974085
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.