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

    ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT

    K Number: K895417 · Decision Jan 3, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    64
    Applicant Total
    110
    Review Days
    124

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    Basic Information

    Device Name
    ARROW LARGE-BORE DUAL LUMEN HEMODIALYSIS KIT
    K Number
    K895417
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Arrow Intl., Inc.
    Date Received
    September 1, 1989
    Decision Date
    January 3, 1990
    Product Code
    LFJ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LFJ Catheter, Subclavian

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