510(k) K132972

AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE by Medtronic, Inc. — Product Code DTN

K132972 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE". The FDA issued a decision of Substantially Equivalent on October 28, 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.