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    K Number
    K070515
    Device Name
    A-VIEW BASIC AND PLUS
    Manufacturer
    CORDATEC N.V.
    Date Cleared
    2007-07-30

    (158 days)

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

    CORDATEC N.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    A-View® catheters are intended for use in conjunction with TEE investigation of the upper mediastinum in anaesthetised 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 Catheters are limited for use in adult patients.
    Device Description
    A-View Basic consists of only the catheter itself. The A-View catheter has three tubes connected by a Y-connector of which one holds a distal, large balloon, one holds a small, pilot balloon and the third holds a stop cock with two standard female luer connections. Both balloons are clear and colorless. On the main shaft a distance mark indicating 24 cm from the closest balloon shoulder is pointed out. A-View Plus consists of the catheter plus a standard 50 ml syringe with luer connector and a swivel Y-connector.
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