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510(k) Data Aggregation

    K Number
    K182463
    Device Name
    Silicone Foley Catheter
    Date Cleared
    2019-11-06

    (422 days)

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

    Biosensors International Pte Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    This product is used for temporary urethral catheterization or indwelling catheterization and bladder irrigation.
    Device Description
    The Silicone Foley Catheter uses the pressure of the bladder to excrete urine. The balloon of the catheter can be inflated and fixed the catheter in place after being injected with a sterile liquid. Foley catheter (2-way) can be used for bladder drainage, and Foley catheter (3-way) also can be used for bladder irrigation. Female type Foley Catheter is equipped with the advancer which can be used instead of tweezers during the catheterization. The Silicone Foley Catheter is for single use, is intended for short-term (less than 14 days) use, and is provided with sterile.
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