510(k) K020106 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
VISION BLOOD CARDIOPLEGIA SYSTEM AND EXTRACORPOREAL HEAT EXCHANGER
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Apr 10, 2002 |
| Received | Jan 11, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020106
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.