510(k) K233091

Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT) by Qura S.R.L — Product Code KFM

K233091 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated Sensors (CP37V-VT); Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors (CP22V-VT)". The FDA issued a decision of Substantially Equivalent on October 26, 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.