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510(k) Data Aggregation

    K Number
    K170030
    Device Name
    NOVATECH TALCAIR
    Manufacturer
    NOVATECH S.A.
    Date Cleared
    2017-03-13

    (68 days)

    Product Code
    GCJ
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVATECH S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is intended for manual insufflation of medical grade talc into the pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
    Device Description
    NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial. The device is a sterile, single use medical device which is sterilized by gamma sterilization. The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started. The device is intended for manual insufflation of medical grade talc into the pleural cavity during pleurodesis. The device is indicated for use according to the approved indication for use of the medical grade talc.
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    K Number
    K151832
    Device Name
    NOVATECH TALCAIR
    Manufacturer
    NOVATECH S.A.
    Date Cleared
    2016-03-31

    (269 days)

    Product Code
    GCJ, GCI
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    NOVATECH S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of malignant pleural effusion by insufflation of medical grade talc following drainage of pleural fluid.
    Device Description
    NOVATECH® TALCAIR™ is a powder blower comprised of an insufflation cannula, an insufflation bulb and its connecting pieces (a coupling, and a luer connector). The coupling, which is made of polypropylene, is used to attach the device to a vial. The device is a sterile, single use medical device which is sterilized by gamma sterilization. The coupling will be inserted into the glass vial. The cannula, made of polyethylene, is attached to the exit of the coupling. The insufflation bulb has two valves and a tube. The bulb and the tube are made of Soft-PVC. The luer connector, made of radiation grade polycarbonate, is attached to the tube of the insufflation bulb. The luer connector is to be attached to the coupling. When ready for use, the coupling is to be firmly pressed onto the vial until the coupling "clicks" on the vial top. Attach the balloon to the coupling with the luer connector. For administration, the cannula is introduced into the body cavity and pulverization is started. The medical device is intended for the administration of medical grade talc via thoracoscopy. The device is intended to treat patients with malignant pleural effusion.
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    K Number
    K971509
    Device Name
    ENDOXANE
    Manufacturer
    Novatech S.A.
    Date Cleared
    1997-08-21

    (118 days)

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

    Novatech S.A.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The main indications according to their frequency are : - 1. tracheobronchial tumors - 2. Tracheal stenosis with scarring - 3. Bronchial stenosis after surgical anastomotic, anastomoses resections or pulmonary transplantation. These stenoses have, as a common characteristic, the importance of the extrinsic compression or the collapse of the cartilingeous wall. The indication always focuses on an endoscopic therapeutic action, whether is concerns a resection or dilation. The stent insertion is indicated if the endoscopic resection is incomplete, in case of a persistent extrinsic compression, or if the lumen is insufficient. The most frequent locations are tracheal. The left main bronchus is the second location, followed by the right main bronchus.
    Device Description
    the ENDOXANE® is an endoscopy stent made of silicone. This stent, the most fitted in the world, is presented as a silicone tube with stubs allowing to avoid any movement. The non armed polysiloxane is covered with a new coating especially designed in order to keep its' flexibility which facilitates tolerance and evacuation of secretions. A well-adapted ENDOXANE® does not move and cough reflexes are inhibited by reflex center saturation. The stubs prevent a direct contact between the stent surface and the mucus membrane and distribute the pressures among the small surfaces.
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