BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CYTOSAFE NEEDLE

    K Number: K844904 · Decision Feb 22, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    205
    Applicant Total
    16
    Review Days
    67

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    Basic Information

    Device Name
    CYTOSAFE NEEDLE
    K Number
    K844904
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5440
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Baxa Corp., Sub. of Cook Group, Inc.
    Date Received
    December 17, 1984
    Decision Date
    February 22, 1985
    Product Code
    LHI
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    LHI Set, I.V. Fluid Transfer

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    Other Clearances by Baxa Corp., Sub. of Cook Group, Inc.

    K Number Device Name
    K910257 BAXA PCA INFUSOR
    K903159 VALVE CONTROLLER FOR MICROMACRO COMPOUNDER
    K904225 KWIKMIX
    K900585 TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
    K873875 BAXA EXACTA-MED PHARMACY PUMP
    K872743 BAXA TUBING SETS (FOR PHARMACY PUMP)
    K832332 VENTED I.V. TRANSFER NEEDLE
    K832312 I.V. TRANSFER NEEDLE
    K832347 TWOFER NEEDLE
    K832254 BAXA ADDISEAL
    Search all 16 clearances from Baxa Corp., Sub. of Cook Group, Inc. →