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

    aeris Balloon Dialation Catheter

    K Number: K150951 · Decision Jun 25, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    27
    Applicant Total
    2
    Review Days
    77

    Basic Information

    Device Name
    aeris Balloon Dialation Catheter
    K Number
    K150951
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.4680
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bryan Medical , Inc.
    Date Received
    April 9, 2015
    Decision Date
    June 25, 2015
    Product Code
    KTI
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    Y

    Classifications

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

    Product Code Device Name
    KTI Bronchoscope Accessory

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