510(k) Report

Devices descending from K133261

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

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