510(k) K111972

AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF by Medtronic, Inc. — Product Code KFM

K111972 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF". The FDA issued a decision of Substantially Equivalent on July 27, 2011. 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.