510(k) K081947 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Feb 4, 2009 |
| Received | Jul 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081947
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.