510(k) Report

Devices descending from K082403

6 later devices reach Medos Hilite Oxygenator, Model 7000 & 7000 LT through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K133261Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG20145—
+2K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.20260—
+2K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+3K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+3K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+4K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—