510(k) Report

Devices descending from K141233

1 later device reach Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—