Renal Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
35
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K970648PRIMUS HOLLOW FIBER DIALYZER (MODELS 1000,1000S,1350,1350S,2000,2000S)January 5, 1998
K861730ACTRIL FOR KIDNEY MACHINE DISINFECTANTJune 9, 1987
K854011RENALFO HEMOFILTER CAVHDNovember 5, 1985
K844790RENAFLO HEMOCONCENTRATORMay 23, 1985
K844108RENAL SYSTEMS PERITONEAL ACCESS SYSTEMJanuary 7, 1985
K843963DIALYSATE CONCENTRATE FOR HEMODIALYSIS-LIQUID/POWDJanuary 7, 1985
K842258RENATRONJuly 6, 1984
K841543CONCENTRATE CONDUCTIVITY METERMay 22, 1984
K840182RENAPAK CONCENTRATE MIXING SYS.May 2, 1984
K840437HEMASITE ACCESSORIES MODIFICATIONFebruary 21, 1984
K840436HEMASITE/RENALOY -VASCULAR ACCESS SHUNTFebruary 21, 1984
K834596BLOOD TUBINGFebruary 4, 1984
K834510RENAFLO AVF SET FOR HEMODIALYSISFebruary 4, 1984
K833622RENALLOY HEMASITE VASCULAR ACCESS SHUNTNovember 29, 1983
K833181HPR HOME PATIENT RENATRONOctober 27, 1983
K830575RENALIN (TENTATIVEMarch 31, 1983
K830574RENATRON DIALYZER REPROCESSING SYSMarch 29, 1983
K823546RENAFLO IIDecember 16, 1982
K822880ARTERIO VENOUS SHUNT CANNULA & ADAPTORSOctober 18, 1982
K821001MCPARLAND SCALP VEIN CATHETERJuly 22, 1982