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510(k) Data Aggregation

    K Number
    K123571
    Device Name
    CARDIO VISION MICS AORTIC CLAMPS
    Manufacturer
    CARDIOMEDICAL GMBH
    Date Cleared
    2013-08-01

    (254 days)

    Product Code
    DXC
    Regulation Number
    870.4450
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIOMEDICAL GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cardio Vision® MICS Aortic Clamps are indicated for use for temporary or partial occlusion of blood vessels during surgical procedures.
    Device Description
    Cardio Vision® MICS Aortic Clamps are reusable stainless steel vascular clamps provided with DeBakey tooth design. The closure mechanisms permit the surgeon to adjust the amount of tension applied to the vessel. The length and design of the clamps can be important to keep the devices out of the field of vision of the operative site. Three basic models are available to accommodate the individual needs of the surgeon and the procedure based on the anatomy of the site. Standard Clamp - Ring-handled clamp with ratchet closure o 2nd Generation Clamp -- Handleless clamp with manual screw 0 mechanism closure Clamp by Glauber - Handleless clamp with screw mechanism closure. o The clamp is positioned and removed by means of an applicator and remains wholly within the thorax throughout the duration of the procedure. The device is provided non-sterile for steam sterilization by the user.
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