510(k) K854113 ยท KRI Accessory Equipment, Cardiopulmonary Bypass
CARDIOPLEGIA HEAT EXCHANGER HOLDER HE-100SH
| Applicant | American Bentley, Irvine CA, US |
| Decision | Substantially Equivalent, Jan 8, 1986 |
| Received | Oct 8, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854113
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.