510(k) Report

Devices descending from K230640

1 later device reach Affinity Fusion™ Oxygenator System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems20240—