510(k) Report

Devices descending from K935958

8 later devices reach Crit-Line Blood Chamber with E-Beam through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K141281Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care Renal Therapies Group, LLC20147—
+2K152953Crit-Line Clip (Clic) Blood ChamberFresenius Medical Care North America20156—
+3K201207CombiSet SMARTECH Hemodialysis Blood Tubing Set with attached Priming Set and Integrated…Fresenius Medical Care Renal Therapies Group, LLC20205—
+4K2435055008X Hemodialysis SystemFresenius Medical Care Renal Therapies Group, LLC202516
+4K2315345008X Hemodialysis SystemFresenius Medical Care202421
+4K213992CombiSet Hemodialysis Blood Tubing SetFresenius Medical Care Renal Therapies Group, LLC202311
+5K251851DIASAFEplusUS (F00013010)Fresenius Medical Care Renal Therapies Group, LLC20250—
+5K251442TIANYI Extracorporeal Blood Tubing Set (TY-NDEO-A1)Ningbo Tianyi Medical Appliance Co., Ltd.20250—