510(k) K241352

Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B) by Medtronic, Inc. — Product Code DTZ

K241352 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir (541B)". The FDA issued a decision of Substantially Equivalent on June 12, 2024. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Medtronic, Inc. has at least 10 other 510(k) clearances on record.