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510(k) Data Aggregation

    K Number
    K062302
    Device Name
    MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM
    Manufacturer
    MILLICORE AB
    Date Cleared
    2006-10-06

    (59 days)

    Product Code
    KDQ, KDO
    Regulation Number
    880.6740
    Why did this record match?
    Applicant Name (Manufacturer) :

    MILLICORE AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DigiVent™ Chest Drainage System is indicated to evacuate air and/or fluid from the chest cavity or mediastinum, to help prevent air and/or fluid from reaccumulating in the chest cavity or mediastinum, to help re-establish and maintain normal intrathoracic pressure gradients, and to facilitate complete lung re-expansion and restore normal breathing dynamics.
    Device Description
    The DigiVent™ Chest Drainage System consists primarily of a collection chamber and a Controller Unit. Pressure regulator, drainage tubing (with kink prevention), positive- and negative pressure relief valves, and hangers complete the system. Thoracic catheters (chest tubes) are not included.
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