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

    CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved

    K Number: K142934 · Decision Jun 17, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    163
    Registration Numbers
    163
    Same Product Code
    238
    Applicant Total
    130
    Review Days
    251

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    Basic Information

    Device Name
    CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved
    K Number
    K142934
    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
    Covidien
    Date Received
    October 9, 2014
    Decision Date
    June 17, 2015
    Product Code
    EOQ
    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
    EOQ Bronchoscope (Flexible Or Rigid)

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