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510(k) Data Aggregation

    K Number
    K170338
    Device Name
    A-View
    Manufacturer
    Stroke2Prevent B.V.
    Date Cleared
    2017-05-16

    (103 days)

    Product Code
    ITX
    Regulation Number
    892.1570
    Why did this record match?
    Applicant Name (Manufacturer) :

    Stroke2Prevent B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-View® is intended for use in conjunction with TEE investigation of the upper mediastinum in anesthetized patients. They allow visibility of the distal ascending aorta by TEE and permit the condition of the ascending aorta to be evaluated before surgery. A-View® is limited for use in adult patients.
    Device Description
    The A-View® is a catheter with an inflatable balloon that is inserted through an endotracheal tube of an anesthetized patient. Once inserted the balloon is inflated with saline. This inflated balloon is placed near the aortic arch so that when the clinician is performing a TEE (transesophageal echocardiography) procedure the saline filled balloon provides better contrast for an image.
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