510(k) K122914

AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE by Medtronic, Inc. — Product Code DTN

K122914 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE". The FDA issued a decision of Substantially Equivalent on January 9, 2013. The device falls under product code DTN (Reservoir, Blood, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4400. Medtronic, Inc. has at least 10 other 510(k) clearances on record.