510(k) K031300 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
IBC FLOPUMP WITH GBS COATING
| Applicant | Gish Biomedical, Inc., Houston TX, US |
| Decision | Substantially Equivalent, May 14, 2003 |
| Received | Apr 24, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031300
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.