510(k) K201068

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface by Medtronic, Inc. — Product Code KFM

K201068 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortiva BioActive Surface". The FDA issued a decision of Substantially Equivalent on May 21, 2020. The device falls under product code KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type), a Class II device regulated under 21 CFR 870.4360. Medtronic, Inc. has at least 10 other 510(k) clearances on record.