510(k) K220842
Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors by
Qura S.R.L
— Product Code KFM
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2023
- Date Received
- March 23, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
- Device Class
- Class II
- Regulation Number
- 870.4360
- Review Panel
- CV
- Submission Type