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CAK — Microfilter, Blood Transfusion Class II

FDA Device Classification

Classification Details

Product Code
CAK
Device Class
Class II
Regulation Number
880.5440
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K061103haemoneticsHAEMONETICS 40U RBC FILTER BAGMay 17, 2006
K022477summit medicalSUMMIT MEDICAL LTD TRANSFUSION FILTER, MODEL LF400 & SUMMIT MEDICAL LTD TRANSFUSOctober 25, 2002
K000719whatmanNEOCARE 20 MICRON BLOOD FILTERMay 30, 2000
K990310charter medicalCHARTER MEDICAL, LTD MP 450 (40 MICRON FILTER)August 30, 1999
K982822baxter healthcareFENWAL 20 MICRON PEDIATRIC TRANSFUSION FILTER MODEL 4C7701, FENWAL 20 MICRON PEDSeptember 30, 1998
K972159baxter healthcareFENWAL 40 MICRON TRANSFUSION FILTERJuly 23, 1997
K970225alpha therapeuticALPHA MICRON 20/40 MICROAGGREGATE FILTERFebruary 14, 1997
K960993pall biomedical productsPALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)April 22, 1996
K955515alpha therapeuticALPHA MICRON 20 MICROAGGREGATE FILTERFebruary 12, 1996
K904223baxter healthcareSEPACELL(R) R-200/500 LEUKOCYTE REMOVAL RECIP SETSOctober 26, 1990
K904221baxter healthcareSEPACELL(R) PL-5A/10A LEUKOCYTE REMOVAL FILTERSOctober 26, 1990
K901887asahi medical coMODIFIED SEPACELL R-SERIES BLOOD FILTERSAugust 8, 1990
K896203solco basleSOLCOSEPT(TM) BLOOD TRANSFUSION FILTERFebruary 1, 1990
K896976asahi medical coMODIFIED SEPACELL R-500 AND R-500A BLOOD FILTERSJanuary 24, 1990
K896664asahi medical coMODIFIED SEPACELL PL-SERIES LEUKOCYTE REMOVAL FILTJanuary 24, 1990
K890844arbor technologiesMICROSEPT 60/20June 7, 1989
K873792advocacy internationalSEPACELL R-500 AND SEPACELL R-500AJanuary 19, 1988
K873666pall biomedical productsPALL LEUKOCYTE REMOVAL FILTER, BLOODJanuary 6, 1988
K873667pall biomedical productsPALL LEUKOCYTE REMOVAL FILTER, PLATELETSJanuary 6, 1988
K873873travenol laboratoriesRESUBMITTED MICRON TRANSFUSION FILTEROctober 22, 1987