BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇩🇰 Denmark

    I-PORT ADVANCE INJECTION PORT

    K Number: K120337 · Decision Feb 16, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    204
    Registration Numbers
    205
    Same Product Code
    503
    Applicant Total
    13
    Review Days
    13

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    Basic Information

    Device Name
    I-PORT ADVANCE INJECTION PORT
    K Number
    K120337
    Device Class
    FDA class 2
    Clearance Type
    Abbreviated
    Regulation Number
    880.5200
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Unomedical A/S
    Date Received
    February 3, 2012
    Decision Date
    February 16, 2012
    Product Code
    FOZ
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

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