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

    ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED

    K Number: K121048 · Decision Aug 3, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    432
    Review Days
    119

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    Basic Information

    Device Name
    ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM- STERILE UNCOVERED
    K Number
    K121048
    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
    Boston Scientific Corp
    Date Received
    April 6, 2012
    Decision Date
    August 3, 2012
    Product Code
    JCT
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    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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