510(k) K191077

Affinity CP Centrifugal Blood Pump, Affinity CP Centrifugal Blood Pump with Balance Biosurface, Affinity CP Centrifugal Blood Pump with Cortive BioActive Surface, Medtronic External Drive Motor by Medtronic, Inc. — Product Code KFM

K191077 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 Cortive BioActive Surface, Medtronic External Drive Motor". The FDA issued a decision of Substantially Equivalent on August 27, 2019. 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.