510(k) K944219 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
| Applicant | Gish Biomedical, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Jun 30, 1995 |
| Received | Aug 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K944219
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.