510(k) K191444

Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir by Medtronic, Inc. — Product Code DTZ

K191444 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir". The FDA issued a decision of Substantially Equivalent on Sep 27, 2019. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Medtronic, Inc. has 247 other 510(k) clearances on record.