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

    CLEARLUMEN THROMBECTOMY SYSTEM

    K Number: K140296 · Decision Dec 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    91
    Applicant Total
    9
    Review Days
    299

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    Basic Information

    Device Name
    CLEARLUMEN THROMBECTOMY SYSTEM
    K Number
    K140296
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Walk Vascular, LLC
    Date Received
    February 6, 2014
    Decision Date
    December 2, 2014
    Product Code
    QEZ
    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
    QEZ Aspiration Thrombectomy Catheter

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