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

    HEMOFILTRATION CATHETER HF-100

    K Number: K840322 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    19
    Review Days
    90

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    Basic Information

    Device Name
    HEMOFILTRATION CATHETER HF-100
    K Number
    K840322
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Vas-Cath of Canada , Ltd.
    Date Received
    January 25, 1984
    Decision Date
    April 24, 1984
    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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