510(k) Report

Devices descending from K100645

4 later devices reach Affinity Pixie Oxygenation System with Carmeda Bioactive Surface or Balance… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with…Medtronic, Inc.20170—
+1K160091Temperature Probe, Affinity Temperature ProbeMedtronic, Inc.20160—
+1K141233Affinity Pixie Oxygenation System with; Carmeda Bioactive Surface, Balance BiosufaceMedtronic, Inc.20141—
+1K123448Affinity Flexible Luer Lock Adapter with Balance Biosurface, Affinity Flexible Luer Lock…Medtronic, Inc.20120—