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

    MegaVac Mechanical Thrombectomy System

    K Number: K171493 · Decision Aug 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8
    Same Product Code
    2
    Applicant Total
    1
    Review Days
    80

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    Basic Information

    Device Name
    MegaVac Mechanical Thrombectomy System
    K Number
    K171493
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.5150
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Capture Vascular, Inc.
    Date Received
    May 22, 2017
    Decision Date
    August 10, 2017
    Product Code
    QEX
    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
    QEX Coronary Mechanical Thrombectomy With Aspiration

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