510(k) K050195 ยท DTN Reservoir, Blood, Cardiopulmonary Bypass
V-BAG WITH GBS COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Mar 17, 2005 |
| Received | Jan 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050195
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.