510(k) K870804 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
CARDIOPLEGIA HEAT EXCHANGER MODEL NO. HE-100
| Applicant | American Bentley, Irvine CA, US |
| Decision | Substantially Equivalent, Sep 1, 1987 |
| Received | Feb 27, 1987 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K870804
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.