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510(k) Data Aggregation

    K Number
    K062240
    Device Name
    CAREVENT
    Manufacturer
    CHIEF MEDICAL LLC
    Date Cleared
    2006-10-16

    (75 days)

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

    CHIEF MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The CareVent is intended for use with a Foley Urinary Catheter for the management of urinary drainage.
    Device Description
    The CareVent device is used with a Foley catheter for the management of urinary drainage. The CareVent offers the physician/user a means to temporarily control the flow of urine from the bladder. Temporary control of urine may be desired for bladder conditioning, diagnostic procedures or patient comfort. The CareVent valve is easily inserted into the distal end of a Foley catheter and may be left open for continuous drainage or manually operated for temporarily closure. The device is provided sterile and for single patient use.
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