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510(k) Data Aggregation

    K Number
    K955495
    Device Name
    RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE
    Manufacturer
    RUSCH, INC.
    Date Cleared
    1996-06-27

    (209 days)

    Product Code
    BTR
    Regulation Number
    868.5730
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K844296,K830352
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The device is a single use, sterile, cuffed tracheal intubation and indicated for airway management.

    Device Description

    consists of a clear, implant tested, P.V.C. tube with an encapsulated stainless steel reinforcing spiral. The tube is graduated with multiple centimeter markings to allow easy determination of the intubated length, and is terminated with a fully inserted connector. The tube is fitted with a low pressure, high volume cuff, which is inflated through a lueractivated valve, pilot baloon, inflation tube and lumen in the wall of the main tube.

    AI/ML Overview

    The provided document is a 510(k) Substantial Equivalence Summary for the Rusch Reinforced Tracheal Tube - Cuffed, sterile. This document is for a medical device regulatory submission and does not contain any information about clinical studies, acceptance criteria, or performance data of the kind requested.

    Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to pre-existing devices based on design, materials, and intended use, rather than presenting results from a performance study against specific acceptance criteria.

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