510(k) Report

Devices descending from K123314

2 later devices reach Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K142784Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…Medtronic, Inc.201411
+2K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…Medtronic, Inc.20170—