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FKT — System, Dialysate Delivery, Sorbent Regenerated Class II

FDA Device Classification

Classification Details

Product Code
FKT
Device Class
Class II
Regulation Number
876.5600
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K123835renal solutions2008 HEMODIALYSIS SORBENT SYSTEMFebruary 15, 2013
K093362renal solutions2008 HEMODIALYSIS SORBENT SYSTEMAugust 13, 2010
K070739renal solutionsALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL# 1500May 25, 2007
K060381renal solutionsALLIENT SORBET HEMODIALYSIS SYSTEM, MODEL 1100May 24, 2006
K043574renal solutionsALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000June 3, 2005
K031099renal solutionsSORB+HISORB+CARTRIDGESeptember 17, 2003
K954623gambro healthcareREDY 2000 SYSTEM (THERAPEUTIC PLASMA EXCHANGE OPTION AND MONITORING LINE Y-CONNEAugust 28, 1996
K882428organon teknikaREDY 2000October 25, 1988
K874137ash medical systemsMODIFIED BIOLOGIC 1000 HEMODIAL. & HD-1000 DIS CARApril 8, 1988
K870270ash medical systemsMODIFIED BIO. HEMODIALYSIS & HD-1000 DISP. CART.February 25, 1987
K864179ash medical systemsBIOLOGIC 1000 HEMODIALYSIS MACH/HD-1000 DISP CARTRDecember 11, 1986
K851188organon teknikaPACKETS FOR PREP. OF DIALYSATES & INFUSATES -April 12, 1985
K842513organon teknikaHEMOPERFUSION PROCEDURE W/REDY 2000September 12, 1984
K813574organon teknikaSORB IIMarch 23, 1982
K812869organon teknikaD-3260 SORBENT CARTRIDGEDecember 8, 1981
K811170organon teknikaD-3160 SORBENT CARTRIDGEJuly 31, 1981
K801440organon teknikaSORB 10 DIALYSATE INFUSATE C1 INFUSATEJuly 21, 1980
K801385organon teknikaK1 POTASSIUM ACETATE ADDITIVEJuly 21, 1980
K792137organon teknikaSORB SYSTEM URSJanuary 16, 1980