510(k) K201320

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor by Qura S.R.L — Product Code KFM

K201320 is an FDA 510(k) premarket notification submitted by Qura S.R.L for the device "Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor". The FDA issued a decision of Substantially Equivalent on November 3, 2021. 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.