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510(k) Data Aggregation

    K Number
    K121462
    Device Name
    EZ-BLOCKER
    Manufacturer
    Date Cleared
    2012-09-28

    (134 days)

    Product Code
    Regulation Number
    868.5740
    Why did this record match?
    Applicant Name (Manufacturer) :

    EZ-BLOCKER B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The EZ-Blocker is indicated for use to intubate the patient's bronchi in order to differentially isolate the left or right lung for procedures which require one-lung ventilation, lung separation. Patient population: Patients requiring one lung isolation. Environment of use: Hospitals - OR and ICU.
    Device Description
    The EZ-Blocker is a double lumen endobronchial tube made of polymer materials and inks. The distal part of the tube ends in a "y" shape with distal extensions for each branch of the lung. The extensions are symmetrical and colored differently (blue and yellow) for identification purposes. The device is supplied with an adapter for connection to a ventilator device. The symmetrical design facilitates introduction and positioning of the device in both main stem bronchi. When properly positioned, the cuff in the main stem branches of the non-ventilated lung can be inflated and lung isolation is achieved.
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