510(k) K913691 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
| Applicant | Gish Biomedical, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, Dec 18, 1991 |
| Received | Aug 19, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913691
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.