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    K Number
    K223542
    Device Name
    TubaVent Balloon Dilatation System
    Manufacturer
    Spiggle & Theis Medizintechnik GmbH
    Date Cleared
    2023-08-03

    (251 days)

    Product Code
    PNZ
    Regulation Number
    874.4180
    Why did this record match?
    Applicant Name (Manufacturer) :

    **Spiggle **& Theis Medizintechnik GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TubaVent balloon dilatation system is intended to dilate the cartilaginous portion of the Eustachian tube for treatment of persistent obstructive Eustachian tube dysfunction in patients 18 years and older.
    Device Description
    The TubaVent balloon dilatation system is an Eustachian Tube Balloon Dilatation System consisting of the balloon catheter, the Tubalnsert insertion device and the inflation device. It is used for dilation of the cartilaginous portion of the Eustachian tube in persistent obstructive Eustachian tube dysfunction. The balloon catheter TubaVent is available in two versions where the balloon diameter is different: 3 and 4.5 mm. The insertion device Tubalnsert has an angle of 45° at the distal end.
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