510(k) K190650 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Revolution Centrifugal Blood Pump
| Applicant | Sorin Group Italia S.R.L., Mirandola, IT |
| Decision | Substantially Equivalent, Aug 7, 2019 |
| Received | Mar 13, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190650
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.