510(k) Report

Devices descending from K961530

10 later devices reach Gish Reliance Oxygenator (Model Hfo) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K082403Medos Hilite Oxygenator, Model 7000 & 7000 LTGish Biomedical, Inc.20096—
+1K080708Vision Hollow Fiber Oxygenator with HA CoatingGish Biomedical, Inc.20090—
+1K023381Vision Hollow Fiber Oxygenator with Guardian CoatingGish Biomedical, Inc.200322
+2K133261Medos Hilite 7000 & 7000 LT OxygenatorMedos Medizintechnik AG20145—
+2K031300Ibc Flopump with GBS CoatingGish Biomedical, Inc.20030—
+3K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.20260—
+3K191407Novalung SystemFresenius Medical Care Renal Therapies Group, LLC202032
+4K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+4K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+5K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—