510(k) Report

Devices descending from K203111

2 later devices reach Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.20231—
+2K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems20240—