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

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    K Number: K050832 · Decision Jul 7, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    28
    Registration Numbers
    28
    Same Product Code
    44
    Applicant Total
    34
    Review Days
    97

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    Basic Information

    Device Name
    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT
    K Number
    K050832
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.3720
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Bard Peripheral Vascular, Inc.
    Date Received
    April 1, 2005
    Decision Date
    July 7, 2005
    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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