510(k) Report

Devices descending from K183511

3 later devices reach Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation SystemMedtronic202126
+2K230640Affinity Fusion™ Oxygenator SystemMedtronic, Inc.20231—
+3K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic Perfusion Systems20240—