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

    PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS

    K Number: K093414 · Decision Mar 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    57
    Registration Numbers
    57
    Same Product Code
    287
    Applicant Total
    52
    Review Days
    119

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    Basic Information

    Device Name
    PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS
    K Number
    K093414
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5965
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Smiths Medical Asd, Inc.
    Date Received
    November 2, 2009
    Decision Date
    March 1, 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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