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510(k) Data Aggregation

    K Number
    K213028
    Device Name
    Tenax Laser Resistant Endotracheal Tube
    Manufacturer
    Bryan Medical , Inc.
    Date Cleared
    2021-10-21

    (30 days)

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

    Bryan Medical , Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Tenax® Laser Resistant Endotracheal Tube is intended for endotracheal intubation. It is indicated for use for all types of surgical procedures involving carbon dioxide (10.60 microns), KTP (532 nm) or Blue Laser (445mm) laser use (normal pulsed or continuous beam delivery in the non-contact mode), when endotracheal intubation is required to administer anesthetic gases or to overcome emergency obstruction of an airway.
    Device Description
    The Tenax® Laser Resistant Endotracheal Tube is an endotracheal tube with two inflatable cuffs. It is indicated for use in surgical procedures where intubation is required in the presence of KTP, 445nm Blue Laser, or CO2 lasers. The device is provided sterile (EO). After use, the device is discarded and disposed of in accordance with local regulations. There are no associated device accessories.
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    K Number
    K150951
    Device Name
    aeris Balloon Dialation Catheter
    Manufacturer
    Bryan Medical , Inc.
    Date Cleared
    2015-06-25

    (77 days)

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

    Bryan Medical , Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The aeris Balloon Dilation Catheter is intended for use in adult and pediations to dilate strictures of the airway.
    Device Description
    The aeris Balloon Dilation Catheter is comprised of a sinqle lumen catheter with a high pressure balloon near the distal tip. A stylet is provided to facilitate advancement of the balloon dilation catheter to the desired location. The stylet must be removed before inflation of the high pressure balloon. A luer lock at the proximal end is used for placement of the stylet and injecting sterile water into the balloon. Two radiopaque markers, located on the catheter, inside the balloon, can be used to confirm balloon placement under Fluoroscopy. The aeris Balloon Dilation Catheter includes inflation balloons of diameters 5, 7, 8, 9, 10, 12, 14, and 16 mm with complementing characteristics as shown in Table 1.
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