BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    Relieva Tract Balloon Dilation System

    K Number: K183090 · Decision Apr 19, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    0
    Applicant Total
    45
    Review Days
    164

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    Basic Information

    Device Name
    Relieva Tract Balloon Dilation System
    K Number
    K183090
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    874.4420
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Acclarent, Inc.
    Date Received
    November 6, 2018
    Decision Date
    April 19, 2019
    Product Code
    QGK
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QGK Balloon, Nasal Airway

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