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

    ARGON DUAL LUMEN HEMODIALYSIS, CATHETER

    K Number: K842039 · Decision Jan 29, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    9
    Applicant Total
    27
    Review Days
    253

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    Basic Information

    Device Name
    ARGON DUAL LUMEN HEMODIALYSIS, CATHETER
    K Number
    K842039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Argon Medical Corp.
    Date Received
    May 21, 1984
    Decision Date
    January 29, 1985
    Product Code
    KNZ
    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
    KNZ Accessories, A-V Shunt

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