510(k) Report

Devices descending from K191407

3 later devices reach Novalung System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K240880VitalFlow Set with Balance BiosurfaceMedtronic, Inc.20241—
+1K232926Novalung ultimate kit (US)Fresenius Medical Care Renal Therapies Group, LLC20240—
+2K261335VitalFlow Set with Balance™ BiosurfaceMedtronic, Inc.20260—