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510(k) Data Aggregation

    K Number
    K983000
    Device Name
    CRICOTHYROTOMY TUBE
    Manufacturer
    POLAMEDCO, INC.
    Date Cleared
    1999-10-27

    (426 days)

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

    POLAMEDCO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this device is to permit conventional ventilation, suctioning, and spontaneous ventilation on the part of an adult patient after insertion of the device in an incision at the cricothyriod space. The Tracheony Tube for Emergency Cricothyrotomy is intended for emergency surgical crioothyrotomy.
    Device Description
    Polamedco's Tracheostomy Tube for Emergency Cricothyrotomy is designed for use by EMT's, Paramedics, E.R. Physicians, Anesthesiologists and R.N.'s. The length of the device is longer than a tracheostomy tube with comparable internal diameter/outside diameter. The device features a beveled smooth rounded tip that minimizes trauma. The device is made of flexible medical grade PVC. Features full radiopaque line for tube depth visualization. Packaged Sterile and single use. Latex Free. The device is made with heavy metal free materials that are safe incinerate and autoclave. Available in: 5.5 mm., 6.0 mm and 6.5 mm. ID sizes.
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