510(k) K203111

Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System by Medtronic — Product Code DTZ

K203111 is an FDA 510(k) premarket notification submitted by Medtronic for the device "Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System". The FDA issued a decision of Substantially Equivalent on September 16, 2021. The device falls under product code DTZ (Oxygenator, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4350. Medtronic has at least 10 other 510(k) clearances on record.