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510(k) Data Aggregation

    K Number
    K251313

    Validate with FDA (Live)

    Device Name
    Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Distal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT with TaperGuard™ Cuff, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Distal with Disposable Inner Cannula ; Shiley™ Adult Flexible Tracheostomy Tube XLT Cuffless, Proximal with Disposable Inner Cannula; Shiley™ Adult Flexible Disposable Inner Cannula XLT
    Manufacturer
    Covidien, LLC
    Date Cleared
    2025-12-29

    (245 days)

    Product Code
    JOH
    Regulation Number
    868.5800
    Type
    Traditional
    Panel
    Anesthesiology
    Age Range
    18 - 999
    Reference & Predicate Devices
    K051416,K150844,K142296
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K051416, K150844

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    These devices are intended for use in providing tracheal access for airway management.
    These devices are also intended for use with percutaneous dilatational tracheotomy (PDT) procedures.

    Device Description

    The subject devices are sterile, single use dual cannula tracheostomy tube that has 90° curve and biocompatible radiopaque outer cannula with a distal or proximal extension (XLT) designed for patients with challenging anatomy.

    All tracheostomy tubes feature flexible disposable inner cannula with full circumference at proximal end and a flexible laser-etched flange with integrated standard 15mm connector. The cuffed devices are provided with low-pressure TaperGuard™ cuff, featuring a thin compliant wall that, when inflated, adapts and conforms to the irregular borders of the tracheal wall. The cuffed devices have an inflation system consisting of an inflation line, pilot balloon and self-sealing inflation valve, allowing for inflation and deflation of the cuff.

    The subject devices are manufactured from medical grade polyvinyl chloride (PVC) with non-Di(2-ethylhexyl) phthalate (DEHP) plasticizer and are sterilized by ethylene oxide (EO) sterilization method.

    The cuffed and cuffless configurations of subject devices with distal and proximal extensions are available in four (4) sizes from 5.0mm to 8.0mm.

    AI/ML Overview

    N/A

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