510(k) K192850 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Quantum PureFlow Centrifugal Blood Pump CP37, Quantum PureFlow Centrifugal Blood Pump CP22
| Applicant | Qura S.R.L, Mirandola, IT |
| Decision | Substantially Equivalent, Apr 13, 2020 |
| Received | Oct 3, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K192850
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.