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FKQ — System, Dialysate Delivery, Central Multiple Patient Class II

FDA Device Classification

Classification Details

Product Code
FKQ
Device Class
Class II
Regulation Number
876.5820
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K052764b. braun medizintechnologieDIACAP ULTRA DIALYSIS FLUID FILTERJune 9, 2006
K893612national medical care, medical products divTWO TANK DISSOLUTION MODULEJuly 24, 1989
K874084national medical care, medical products divMULTIPLE ARTIFICIAL KIDNEY SYSTEMS (MAKS) #IDMApril 27, 1988
K873421kawasumi laboratories coKAWASUMI A.V. FISTULA SETOctober 9, 1987
K870889d.r.g. scientific industriesACID FUCHSIN SOLUTIONSJuly 8, 1987
K861730renal systemsACTRIL FOR KIDNEY MACHINE DISINFECTANTJune 9, 1987
K864635national medical care, medical products divFOUR TANK DISSOLUTION MODULEJanuary 13, 1987
K862304cd medicalDRAKE WILLOCK CENTRAL DIALYSATE DELIVERY SYSTEMSeptember 9, 1986
K861472national medical care, medical products divMAKS CENTRAL DELIVERY SYSTEMS MODELS 11-425/11-445July 10, 1986
K852359amuchina intlAMUCHINA/DIALYZER DISINFECTANTMay 13, 1986
K860297renal hygienicsHEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVESMarch 4, 1986
K860336breem laboratoriesHEMODIALYSIS CONCENTRATES AND RELATED PRODUCTSMarch 4, 1986
K860296physicians surgeons purchasing groupHEMODIALYSIS CONCENTRATE FORMULATIONS/ADDITIVESMarch 4, 1986
K854391dana laboratoriesHEMODIALYSIS CONCENTRATEJanuary 8, 1986
K852749mesa medicalRECOMMENDED ALTERNATIVE DIALYZER DISINFECTANTSeptember 10, 1985
K852310erikaNATURALYTE BICARBONATE CONCENTRATE-DRY PACKJuly 26, 1985
K844734alcideALCIDE REN NEW-DMay 17, 1985
K844850medicorpMEDICORP DEHYDRACON A DEHYDRATED DIALYSATE CONCENTApril 2, 1985
K844750seratronicsFRESENIUS A2008 HEMODIALYSIS MACHINE EXPANSION MODFebruary 15, 1985
K844641seratronicsFRESENIUS HAEMODIALYSIS ;MACHINE A1008February 14, 1985