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

    OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER

    K Number: K140286 · Decision Mar 7, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    4
    Review Days
    30

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    Basic Information

    Device Name
    OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER
    K Number
    K140286
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cordis, A Johnson & Johnson Co.
    Date Received
    February 5, 2014
    Decision Date
    March 7, 2014
    Product Code
    DTK
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DTK Filter, Intravascular, Cardiovascular

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    Other Clearances by Cordis, A Johnson & Johnson Co.

    K Number Device Name
    K013581 CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
    K012090 CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT
    K992755 CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, CORDIS CRIMPING TOOLS, CORDIS INTRODUCER TUBE