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

    SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260

    K Number: K831440 · Decision Jun 3, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    11
    Review Days
    29

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    Basic Information

    Device Name
    SINGLE NEEDLE SUBCLAVIAN VEIN MWI250/260
    K Number
    K831440
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Med-West, Inc.
    Date Received
    May 5, 1983
    Decision Date
    June 3, 1983
    Product Code
    FIQ
    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
    FIQ Cannula, A-V Shunt

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