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510(k) Data Aggregation

    K Number
    K242921
    Device Name
    5300600-5301000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, sizes 6.0-10.0mm; 5310600-5311000 Rota-Trach Disposable Standard Tracheostomy Tube, Cuffed, Fenestrated, sizes 6.0-10.0mm; 5400600-5401000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, sizes 6.0-10.0mm; 5410500-5411000 Rota-Trach Disposable Standard Tracheostomy Tube, Uncuff, Fenestrated, sizes 6.0-10.0mm
    Manufacturer
    Vitaltec Corporation
    Date Cleared
    2025-06-10

    (259 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vitaltec Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients.
    Device Description
    Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation.
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    K Number
    K100480
    Device Name
    ROTA-TRACH TRACHEOSTOMY TUBE MODEL ROTA-TRACH
    Manufacturer
    VITALTEC CORPORATION
    Date Cleared
    2010-06-11

    (113 days)

    Product Code
    BTO
    Regulation Number
    868.5800
    Why did this record match?
    Applicant Name (Manufacturer) :

    VITALTEC CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tracheostomy Tubes are intended for use in providing direct tracheal access for airway management.
    Device Description
    The VITALTEC Rota-Trach Tracheostomy Tubes are made from the raw material of The VITALIEC Kota Track Track Tracksonsyland of connector and valve. The the seeff with Sincolle for medical ass, while the components of the propriate hardness, the cuff with tubes have such good perfectionsment tube and excellent biocompatibility.
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