510(k) K944267 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
| Applicant | Cobe Cardiovascular, Inc., Arvada CO, US |
| Decision | Substantially Equivalent, Apr 28, 1995 |
| Received | Sep 1, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944267
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.