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KSR — Container, Empty, For Collection & Processing Of Blood & Blood Components Class II

FDA Device Classification

Classification Details

Product Code
KSR
Device Class
Class II
Regulation Number
864.9100
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K032827tyco healthcareKENDALL LIFETRACE UMBILICAL BLOOD COLLECTION KIT, CODE 56501December 8, 2003
K020753deroyalDEROYAL SURGICAL, UMBILICUPJune 13, 2002
K810897alpha therapeuticALPHA PLASTIC PLASMA BOTTLESeptember 23, 1981
K810500delmedBLOOD FREEZING BAGSeptember 23, 1981
K811523terumo americaPLASMA FLEXSeptember 9, 1981
K811449haemoneticsHAEMONETICS 1000ML COMPONENT BAGJuly 1, 1981
K810711haemoneticsHAEMONETICS 600 ML. COMPONENT BAGMay 8, 1981
K810313haemoneticsHAEMONETICS 1400 ML THERAPEUTIC BAGMarch 31, 1981
K801219north american biologicalsPLASMAPOOLEROctober 31, 1980
K801082gambroGAMBRO HEMOFREEZE-BAGOctober 31, 1980
K792395pharmachemPHARMAFLEX CRYOGENIC BAGFebruary 26, 1980
K792185cry-o-safePIASMA SAFEDecember 28, 1979
K791673delmedEMPTY TRANSFER BAGOctober 23, 1979
K781811travenol laboratoriesTRANSFER PAK 4R 9006November 8, 1978
K780354travenol laboratoriesCRYOCYTE PACKJune 14, 1978
K760952dravon medicalTERASAKI LYMPHOCYTE TRANSPORT KITJanuary 17, 1977