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

    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM

    K Number: K081523 · Decision Sep 11, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    35
    Applicant Total
    6
    Review Days
    101

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    Basic Information

    Device Name
    EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
    K Number
    K081523
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1250
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Abbott Vascular-Vascular Solutions
    Date Received
    June 2, 2008
    Decision Date
    September 11, 2008
    Product Code
    NTE
    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
    NTE Temporary Carotid Catheter For Embolic Capture

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    Other Clearances by Abbott Vascular-Vascular Solutions

    K Number Device Name
    K090665 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19
    K090509 FOXCROSS .035 PTA CATHETER 14 MM X 20MM X 80 CM, MODEL 10342-20, FOXCROSS .035 PTA CATHETER
    K072708 ABSOLUTE PRO .035 SELF-EXPANDING STENT SYSTEM
    K080264 MODIFICATION TO: FOX PLUS PTA CATHETER
    K072798 VIATRAC 14 PLUS PERIPHERAL DILATION CATHETER