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

    RAAF DUAL LUMEN CATH. REPAIR KIT 2.2

    K Number: K834225 · Decision Feb 13, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    90
    Registration Numbers
    90
    Same Product Code
    301
    Applicant Total
    164
    Review Days
    69

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    Basic Information

    Device Name
    RAAF DUAL LUMEN CATH. REPAIR KIT 2.2
    K Number
    K834225
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5970
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Quinton, Inc.
    Date Received
    December 6, 1983
    Decision Date
    February 13, 1984
    Product Code
    LJS
    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
    LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days

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