510(k) K896807 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
| Applicant | Gish Biomedical, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Jul 31, 1990 |
| Received | Dec 4, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896807
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.