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510(k) Data Aggregation

    K Number
    K040657
    Device Name
    BOUSSIGNAC/VYGON ENDOTRACHEAL TUBE, MODEL 6501.25/30/35 AND 6502.70/75/80
    Manufacturer
    VYGON S A
    Date Cleared
    2004-06-10

    (90 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Why did this record match?
    Applicant Name (Manufacturer) :

    VYGON S A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boussignac/ Vygon Endotracheal Tube is indicated for airway management. The insufflation canals permit the delivery of intermittent jet ventilation and the administration of oxygen during tracheobronchial suctioning procedures. They also provide a supplemental means for administering oxygen during bronchoscopies. In these ventilatory modes, the main lumen serves as a channel for the elimination of expired gases. When the insufflation port is capped, The Boussignac/ Vygon Endotracheal Tube can function as a standard tracheal tube with ventilation occurring through the main lumen. The Boussignac/ Vygon Endotracheal Tube is intended for oral/nasal intubation. The monitoring/irrigation lumens may be used for monitoring airway pressure, for irrigation of a patient's tracheobronchial tree, to aid in the removal of accumulated secretions, for sampling tracheal gases, for anesthetizing the trachea, or for introducing suitable medication in accordance with standard medical practice.
    Device Description
    The Boussignac/ Vygon Endotracheal Tube is a standard endotracheal tube available in pediatric and adult use. The tube design includes a Magill curve, a tip, printed depth markings (in one centimeter increments), a low-pressure cuff (adult models only) and self-sealing valve with attached pilot balloon for cuff inflation/deflation. The tube also features a radiopaque line to assist in radiographic visualization. The device, including featured characteristics listed above, conforms to ISO 5361: Anesthetic and Respiratory Equipment – Tracheal Tubes and Connectors. The tube has a main lumen and eight (8) separate canals, or "capillaries", embedded in the tube wall. For adult models, six (6) of these canals are used for gas insufflation, two (2) for pressure control, CO2 monitoring, or irrigation, and as in any endotracheal tube, one (1) for pressure control. CO2 monitoring, or irrigation. For the uncuffed pediatric model, six (6) of the imbedded canal is reserved for gas insufflation, while two (2) are used for pressure control, CO2 monitoring, or irrigation.
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    K Number
    K013884
    Device Name
    BOUSSIGNAC C.P.A.P. DEVICE
    Manufacturer
    VYGON S A
    Date Cleared
    2003-01-21

    (424 days)

    Product Code
    BYE
    Regulation Number
    868.5965
    Why did this record match?
    Applicant Name (Manufacturer) :

    VYGON S A

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Boussignac® C.P.A.P. Device is intended to provide CPAP to spontaneously breathing patients in the hospital and pre-hospital environment.
    Device Description
    The Boussignac® C.P.A.P. Device is a sterile, single-use, respiratory aid device intended for use with a facemask and gas-supplying device to elevate pressure in a patient's lung. Alternatively, the device may be used in conjunction with an endotracheal tube (via a specific Vygon adapter) to generate and maintain constant positive airway pressure during standard intubation procedures. The upper, or proximal, port of the device may be connected to a gas-supplying source via an attached connecting tube, while the lower, or distal port may provide for C.P.A.P. pressure monitoring, O2 monitoring, or an additional source of oxygen in the event that the gas administered to the patient via the proximal connection is air not enriched with oxygen.
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