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

    INFUSE-A-PORT ADDITIONAL SIZES

    K Number: K872329 · Decision Nov 13, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    3
    Review Days
    149

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    Basic Information

    Device Name
    INFUSE-A-PORT ADDITIONAL SIZES
    K Number
    K872329
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Shiley Infusaid, Inc.
    Date Received
    June 17, 1987
    Decision Date
    November 13, 1987
    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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    Other Clearances by Shiley Infusaid, Inc.

    K Number Device Name
    K881745 INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER
    K872898 POLYURETHANE CATHETER FOR THE INFUSE-A-PORT