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

    VASCULAR-ACCESS PORT - ENLARGEMENT

    K Number: K841149 · Decision Apr 24, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    58
    Registration Numbers
    58
    Same Product Code
    285
    Applicant Total
    19
    Review Days
    109

    Basic Information

    Device Name
    VASCULAR-ACCESS PORT - ENLARGEMENT
    K Number
    K841149
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    NORFOLK MEDICAL PRODUCTS, INC.
    Date Received
    January 6, 1984
    Decision Date
    April 24, 1984
    Product Code
    LJT
    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
    LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

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