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510(k) Data Aggregation

    K Number
    K190630
    Device Name
    SolidAIRity III Airway Stabilization System
    Date Cleared
    2019-10-09

    (211 days)

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

    Securisyn Medical, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SolidAIRity III Endotracheal Standard Tube is indicated for airway management of patients requiring oral intubation. The SolidAIRity III Endotracheal Suction Tube is indicated for airway management of patients requiring oral intubation and for evacuation and drainage of subglottic secretions that accumulate above the cuff. The SolidAIRity III Endotracheal Tube Stabilizer is indicated for airway management of patients by securing a SolidAIRity III Endotracheal Tube during oral intubation.
    Device Description
    The SolidAIRity III Airway Stabilization System consists of: - Two (2) types of Oral Endotracheal Tubes (the SolidAIRity III Standard Oral Endotracheal Tube or the SolidAIRity III Suction Oral Endotracheal Tube), and - The SolidAIRity III Endotracheal Tube Stabilizer Each type (standard and suction) of the SolidARity III Oral Endotracheal Tubes will be available in the following five (5) adult sizes: - 6.0mm ID - 6.5mm ID - 7.0mm ID - 7.5mm ID - 8.0mm ID A clinician inserts the endotracheal tube into a patient's trachea, via the mouth, in accordance with standard clinical technique to maintain an open airway. The stabilizer remains outside the patient's mouth and, by means of a locking device and straps, secures the endotracheal tube in place.
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