510(k) Report

Devices descending from K122914

2 later devices reach Affinity Fusion Cardiotomy/Venous Reservior with Balance Biosurface Model… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132972Affinity Fusion Cardiotomy/Venous Reservoir with Balance BiosurfaceMedtronic, Inc.201312
+2K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…Medtronic, Inc.20170—