510(k) K013393 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H
| Applicant | A-Med Systems, Inc., West Sacramento CA, US |
| Decision | Substantially Equivalent, Nov 9, 2001 |
| Received | Oct 15, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013393
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.