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

    Option (TM) ELITE Vena Cava Filter 100cm System

    K Number: K143405 · Decision Apr 16, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    22
    Registration Numbers
    22
    Same Product Code
    82
    Applicant Total
    8
    Review Days
    139

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    Basic Information

    Device Name
    Option (TM) ELITE Vena Cava Filter 100cm System
    K Number
    K143405
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.3375
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Rex Medical, L.P.
    Date Received
    November 28, 2014
    Decision Date
    April 16, 2015
    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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