Renal Systems, Inc.

FDA 510(k) & PMA Approved Devices — 35 products

Total Devices35

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K970648	PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)	MSF	1998-01-05	View
510(k)	K861730	ACTRIL FOR KIDNEY MACHINE DISINFECTANT	FKQ	1987-06-09	View
510(k)	K854011	RENALFO HEMOFILTER CAVHD	KDI	1985-11-05	View
510(k)	K844790	RENAFLO HEMOCONCENTRATOR	KDI	1985-05-23	View
510(k)	K844108	RENAL SYSTEMS PERITONEAL ACCESS SYSTEM	FKX	1985-01-07	View
510(k)	K843963	DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWD	FKQ	1985-01-07	View
510(k)	K842258	RENATRON	LIF	1984-07-06	View
510(k)	K841543	CONCENTRATE CONDUCTIVITY METER	FKQ	1984-05-22	View
510(k)	K840182	RENAPAK CONCENTRATE MIXING SYS.	FKQ	1984-05-02	View
510(k)	K840436	HEMASITE/RENALOY -VASCULAR ACCESS SHUNT	FIQ	1984-02-21	View
510(k)	K840437	HEMASITE ACCESSORIES MODIFICATION	KNZ	1984-02-21	View
510(k)	K834596	BLOOD TUBING	KOC	1984-02-04	View
510(k)	K834510	RENAFLO AVF SET FOR HEMODIALYSIS	KNZ	1984-02-04	View
510(k)	K833622	RENALLOY HEMASITE VASCULAR ACCESS SHUNT	FIQ	1983-11-29	View
510(k)	K833181	HPR HOME PATIENT RENATRON	LIF	1983-10-27	View
510(k)	K830575	RENALIN (TENTATIVE	LIF	1983-03-31	View
510(k)	K830574	RENATRON DIALYZER REPROCESSING SYS	LIF	1983-03-29	View
510(k)	K823546	RENAFLO II	KOC	1982-12-16	View
510(k)	K822880	ARTERIO VENOUS SHUNT CANNULA & ADAPTORS	FIQ	1982-10-18	View
510(k)	K821001	MCPARLAND SCALP VEIN CATHETER	LFJ	1982-07-22	View