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    K Number
    K191061
    Device Name
    Optilume Basic Urological Balloon Dilation Catheter
    Manufacturer
    Urotronic Inc
    Date Cleared
    2020-01-02

    (255 days)

    Product Code
    KOE
    Regulation Number
    876.5520
    Why did this record match?
    Applicant Name (Manufacturer) :

    Urotronic Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilume Basic Urological Balloon Dilation Catheter is indicated for the dilation of urethral strictures.
    Device Description
    The Optilume Basic Urological Balloon Dilation Catheter (Optilume Basic) is a 0.038" (0.97 mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume Basic is used to exert radial force to dilate narrow urethral segments (strictures). The distal end of the catheter is a semi-compliant inflatable balloon. The usable length is 75 cm and allows the device to be compatible with the working channel of a standard flexible cystoscope. The device has two radiopaque marker bands that indicate the working length of the balloon. The device is sterilized using ethylene oxide in a Tyvek pouch. Post sterilization the pouched catheter is sealed in a foil pouch with desiccant and contained within a single unit carton.
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