Submission Details
| 510(k) Number | K220842 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 23, 2022 |
| Decision Date | May 19, 2023 |
| Days to Decision | 422 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors
May 2023
Decision
422d
Days
Class 2
Risk
About This 510(k) Submission
K220842 is an FDA 510(k) clearance for the Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors, 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 May 19, 2023, 422 days after receiving the submission on March 23, 2022. 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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