LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250910
    Device Name
    Optilume® High Pressure Urological Balloon Dilation Catheter
    Manufacturer
    Urotronic, Inc.
    Date Cleared
    2025-05-22

    (57 days)

    Product Code
    EZN, KOE
    Regulation Number
    876.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    Urotronic, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Optilume® High Pressure Urological Balloon Dilation Catheter is indicated for dilation of the urinary tract.
    Device Description
    The Optilume® High Pressure Urological Balloon Dilation Catheter is an 0.038" (0.97mm) guidewire and flexible cystoscope compatible over-the-wire (OTW) catheter with a dual lumen design with a tapered atraumatic tip. The Optilume® High Pressure Urological Balloon Dilation Catheter is used to exert radial force to dilate narrow urinary tract segments (strictures). The distal end of the catheter is a non-compliant inflatable balloon. The 75 cm long Optilume® High Pressure Urological Balloon Dilation Catheter is supplied in five balloon diameters ranging from 4-10mm and balloon lengths ranging from 20-80mm. The balloon catheter is supplied sterile for single use.
    Ask a Question

    Page 1 of 1