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

    HEMODIALYSIS CANNULA & FEMORAL CLAMP

    K Number: K760973 · Decision Jan 12, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    70

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    Basic Information

    Device Name
    HEMODIALYSIS CANNULA & FEMORAL CLAMP
    K Number
    K760973
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Rodell Medical, Inc.
    Date Received
    November 3, 1976
    Decision Date
    January 12, 1977
    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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