510(k) K081838 ยท DTR Heat-Exchanger, Cardiopulmonary Bypass
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
| Applicant | Gish Biomedical, Inc., Rancho Santa Margarita CA, US |
| Decision | Substantially Equivalent, Jan 26, 2009 |
| Received | Jun 30, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081838
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.