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510(k) Data Aggregation

    K Number
    K212151
    Device Name
    FLUME catheter
    Manufacturer
    The Flume Catheter Company, Ltd.
    Date Cleared
    2021-11-03

    (117 days)

    Product Code
    EZL
    Regulation Number
    876.5130
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Flume Catheter Company, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The FLUME catheter is intended for the drainage of the urinary tract.
    Device Description
    The FLUME catheter is a sterile indwelling urinary catheter intended for single use. The FLUME catheter is made using polyurethane-based polymers. The catheter has an inflatable retention balloon attached to the catheter has a dual lumen tube. The larger lumen is for draining urine from the urinary tract. The smaller lumen is used to inflate and deflate the balloon with sterile water. The distal end has two opposite eye holes, which are used for drainage. The product is available in size 14 Fr with a smooth shaft.
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