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510(k) Data Aggregation

    K Number
    K242324
    Device Name
    DUTAU-NOVATECH®
    Manufacturer
    Novatech SA
    Date Cleared
    2025-02-06

    (184 days)

    Product Code
    EOQ, EOO
    Regulation Number
    874.4680
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novatech SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DUTAU-NOVATECH® is intended for rigid bronchoscopy. For use in trachea and bronchi. To be used by qualified surgeons during ENT endoscopic procedures. The DUTAU-NOVATECH® is suitable for use for a patient population greater than 5 years of age.
    Device Description
    DUTAU-NOVATECH® is a rigid bronchoscope that consists of a bronchoscope head and replaceable tubes and is fully dismantlable. It is made of medical grade stainless steel. The tracheal tube mounted on the bronchoscope head is inserted into the trachea. The bronchial tube mounted on the bronchoscope head is inserted through the trachea into the bronchi. A telescope and instruments for diagnosis and treatment can be inserted through these tubes into the bronchi (bronchial tube) or the trachea, respectively. To ventilate the patient, the ventilation tube can be connected either to the bronchoscope head or directly to the respective tube. The tubes are colour coded depending on the size and have a scale to measure stenosis. DUTAU-NOVATECH® is supplied unsterile and must be cleaned, disinfected, and sterilized prior to its use.
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    K Number
    K243126
    Device Name
    TRACHEOBRONXANE™ DUMON®
    Manufacturer
    Novatech SA
    Date Cleared
    2024-10-29

    (29 days)

    Product Code
    NWA
    Regulation Number
    878.3720
    Why did this record match?
    Applicant Name (Manufacturer) :

    Novatech SA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For maintaining open the airway, after dilation of the stenosis or resection of the obstruction, in particular in case of: - Tracheobronchial tumors - Tracheal stenoses with scarring - Stenoses following surgical anastomosis, resection or pulmonary transplantation.
    Device Description
    The TRACHEOBRONXANE™ DUMON® stents are flexible tracheobronchial tubes made of medical grade silicone, designed to improve patient respiration capacity while acting as trachea or bronchi support. These medical devices are designed to conform to individual anatomies. Each stent has a specific treatment, to improve the evacuation of mucus in order to limit the risk of obstruction. A large range of shape, thickness and sizes is available depending on the pathology to be treated, patient intrinsic factor and location of the implantation. Indeed, the TRACHEOBRONXANE™ DUMON® range consists of various models which vary from each other in the following characteristics: - The stents type: TD, TF, BD, Y, ST corresponding to various profiles made of silicone with different hardness; - . The dimensions: each profile consists of different sizes in diameter and length; - The radiopacity: stents can be provided radiopaque or not radiopaque; barium sulfate . is added during the manufacturing process in order to make the stent radiopaque which allows obtaining a better visibility by X-rays radiography. The TRACHEOBRONXANE™ DUMON® stents have been designed with studs in order to facilitate their anchorage in the trachea or bronchi (on cartilage rings). The number of stud rows is depending on the stent profile and stent final destination (bronchi or trachea). The TRACHEOBRONXANE™ DUMON® stent holds the respiratory tract open by exerting a radial force.
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