BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    AMStent® Tracheobronchial Covered Stent System

    K Number: DEN230087 · Decision Oct 16, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    301

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    Basic Information

    Device Name
    AMStent® Tracheobronchial Covered Stent System
    K Number
    DEN230087
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    868.3721
    Medical Specialty
    Anesthesiology
    Decision
    Unknown
    Applicant
    Peytant Solutions, Inc.
    Date Received
    December 20, 2023
    Decision Date
    October 16, 2024
    Product Code
    SDB
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    SDB Tracheal Prosthesis With Cover Material Derived From Human Sources