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510(k) Data Aggregation

    K Number
    K172208
    Device Name
    NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet
    Manufacturer
    Date Cleared
    2018-02-16

    (207 days)

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

    NeVap, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is indicated for oral/tracheal intubation for anesthesia, airway management and removal of accumulated subglottic secretions. It is indicated for singlepatient, single-use only.
    Device Description
    The NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with preloaded stylet is a disposable, sterile, single-patient, single use device. The NeVap ASSET is packaged individually and supplied sterile with a standard 15mm connector and preloaded stylet. The NeVap ASSET is a Magill curved construction with primary lumen for patient ventilation. Two (2) narrower lumens within the primary wall are used for cuff inflation and subglottic evacuation (vacuum). A low pressure, conformable cuff is inflated through the inflation line with pilot balloon using a standard 10cc syringe (air only) through a one-way check valve. For evacuation of subglottic secretions, a separate (yellow) suction line, with male fitting, connects to standard hospital vacuum receptacles. Once properly intubated, subglottic secretions are evacuated through the suction appendage just superior to the cuff. To facilitate proper positioning, the suction appendage and lumen line marker are radiopaque.
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