K190650 is an FDA 510(k) clearance for the Revolution Centrifugal Blood Pump. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by Sorin Group Italia S.R.L. (Mirandola, IT). The FDA issued a Cleared decision on August 7, 2019, 147 days after receiving the submission on March 13, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K190650 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 13, 2019 |
| Decision Date | August 07, 2019 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4360 |