K201320 is an FDA 510(k) clearance for the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor. This device is classified as a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II - Special Controls, product code KFM).
Submitted by Qura S.R.L (Mirandola, IT). The FDA issued a Cleared decision on November 3, 2021, 534 days after receiving the submission on May 18, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4360.
| 510(k) Number | K201320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 18, 2020 |
| Decision Date | November 03, 2021 |
| Days to Decision | 534 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 |