510(k) K081054 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
GISH ARTERIAL FILTER WITH HA COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Jan 15, 2009 |
| Received | Apr 14, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081054
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.