Submission Details
| 510(k) Number | K190650 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Traditional
Revolution Centrifugal Blood Pump
Aug 2019
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K190650 is an FDA 510(k) clearance for the Revolution Centrifugal Blood Pump, 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 review panel. Regulated under 21 CFR 870.4360.
Device Classification
| Product Code | KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4360 |
Manufacturer
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