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

    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS

    K Number: K101017 · Decision Jun 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    87
    Review Days
    66

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    Basic Information

    Device Name
    ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS
    K Number
    K101017
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    AngioDynamics, Inc.
    Date Received
    April 12, 2010
    Decision Date
    June 17, 2010
    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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