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    K Number
    K052454
    Device Name
    THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Date Cleared
    2005-09-14

    (8 days)

    Product Code
    NTE
    Regulation Number
    870.1250
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emboshield® Embolic Protection System is indicated for use as a guidewire and embolic protection system to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries. The diameter of the artery at the site of the Filtration Element placement should be between 2.8 mm and 6.2 mm.
    Device Description
    The Emboshield® Embolic Protection System is a temporary percutaneous transluminal filtration system designed to capture embolic material released during angioplasty and stent procedures within carotid arteries. The system consists of the following components: RX BareWire™, RX Delivery Catheter, Filtration Element, and RX Retrieval Catheter.
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    K Number
    K050501
    Device Name
    MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM
    Manufacturer
    ABBOTT VASCULAR DEVICES
    Date Cleared
    2005-03-14

    (14 days)

    Product Code
    FGE
    Regulation Number
    876.5010
    Why did this record match?
    Applicant Name (Manufacturer) :

    ABBOTT VASCULAR DEVICES

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is intended for use in the palliation of malignant neoplasms in the biliary tree.
    Device Description
    The Abbott Vascular Devices Xceed Nitinol Self-Expanding Transhepatic Biliary Stent System is comprised of a delivery system and a self-expanding stent. The delivery system is an over the wire (OTW) system designed to deliver the self-expanding stent to the biliary tree.
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