510(k) K200091 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Capiox iCP Centrifugal Pump
| Applicant | Terumo Cardiovascular Systems Corporation, Ann Arbor MI, US |
| Decision | Substantially Equivalent, Nov 18, 2021 |
| Received | Jan 16, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200091
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.