510(k) K896020 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
| Applicant | Gish Biomedical, Inc., Santa Ana CA, US |
| Decision | Substantially Equivalent, May 17, 1990 |
| Received | Oct 16, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K896020
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.