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510(k) Data Aggregation

    K Number
    K190060
    Device Name
    Urethrotech UCD
    Manufacturer
    Date Cleared
    2019-10-04

    (266 days)

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

    Urethrotech

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Urethrotech Urethral Catheterization Device is intended for use for bladder management including urine drainage, collection and measurement and / or bladder fluid instillation or irrigation.
    Device Description
    The Urethrotech UCD® (Urethral Catheterization Device) 3-way Silicone Foley Balloon Catheter is composed of a silicone tube with an embedded radiopaque blue stripe, a silicone balloon and polyvinylchloride valve and an integrated introducer guidewire. The tube has three lumen for urinary drainage which is to be connected to a urine collection container, one lumen with two-way valve for inflation/deflation of a Foley balloon and one lumen for the integrated removable guidewire made of Nitinol with hydrophilic coating for the introduction of the catheter through the urethra into the bladder to negotiate any prostatic curve or tight external urethral sphincter, and also for irrigation of the bladder after guidewire removal. The UCD® is intended to be used to provide safe urinary tract access through the urethra and into the bladder and to pass fluids to and from the urinary bladder and to provide continuous bladder irrigation of fluids and drainage of urine from the urinary tract. The device is provided sterile and is intended for short-term use (<=30 days).
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