510(k) Report

Devices descending from K132972

1 later device reach Affinity Fusion Cardiotomy/Venous Reservoir with Balance Biosurface through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with…Medtronic, Inc.20170—