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

K220842 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors, Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated Sensors". The FDA issued a decision of Substantially Equivalent on May 19, 2023. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Qura S.R.L has at least 10 other 510(k) clearances on record.