510(k) K193663 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
FloPump 57mL Centrifugal Pump
| Applicant | International Biophysics Corporation, Austin TX, US |
| Decision | Substantially Equivalent, Mar 10, 2021 |
| Received | Dec 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193663
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.