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

    CELSITE IMPLANTABLE ACCESS PORT SYSTEMS

    K Number: K130576 · Decision Apr 2, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    3
    Review Days
    28

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    Basic Information

    Device Name
    CELSITE IMPLANTABLE ACCESS PORT SYSTEMS
    K Number
    K130576
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    B. Braun Interventional Systems, Inc.
    Date Received
    March 5, 2013
    Decision Date
    April 2, 2013
    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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