510(k) K852780 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
BCD PLUS BLOOD CARDIOPLEGIA SYS(HEREAF REFER DEV)
| Applicant | Shiley, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Sep 30, 1985 |
| Received | Jul 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K852780
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.