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510(k) Data Aggregation

    K Number
    K043527
    Device Name
    RELIEVA SINUS BALLOON DILATION CATHETER
    Manufacturer
    EXPLORAMED NC1, INC.
    Date Cleared
    2005-04-05

    (105 days)

    Product Code
    LRC
    Regulation Number
    874.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EXPLORAMED NC1, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Relieva Sinus Balloon Dilation Catheter is intended to provide a means to dilate ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
    Device Description
    The Relieva Sinus Balloon Dilation Catheter will be provided in the following balloon sizes: - 3 mm Sinus Balloon Catheter . - 5 mm Sinus Balloon Catheter . - 7 mm Sinus Balloon Catheter . The family of Relieva Sinus Balloon Dilation Catheters allows for the enlargement of sinus ostia and paranasal spaces with a minimally invasive method. The Relieva Sinus Balloon Dilation Catheters are placed in the narrow opening over a guidewire. Once positioned the balloons are inflated with a high pressure inflation device that provides feedback as to the internal pressure of the balloon. After a few seconds at the desired balloon inflation pressure, the balloon can be deflated and removed or repositioned.
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