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

    AEROmini Tracheobronchial Stent System

    K Number: K181200 · Decision Sep 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    178
    Review Days
    137

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    Basic Information

    Device Name
    AEROmini Tracheobronchial Stent System
    K Number
    K181200
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Merit Medical Systems, Inc.
    Date Received
    May 7, 2018
    Decision Date
    September 21, 2018
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    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
    JCT Prosthesis, Tracheal, Expandable

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