510(k) Report

Devices descending from K191444

1 later device reach Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…Medtronic, Inc.202401