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510(k) Data Aggregation

    K Number
    K141642
    Device Name
    VAPRO INTERMITTENT CATHETER
    Manufacturer
    HOLLISTER, INCORPORATED
    Date Cleared
    2014-08-22

    (64 days)

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

    HOLLISTER, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VaPro™ intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder. The VaPro Plus™ intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
    Device Description
    The VaPro intermittent catheter is a hydrophilic coated, single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity. The VaPro Plus has the addition of a collection bag that is connected to the catheter for use when drainage into a suitable receptacle is not feasible or practical.
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    K Number
    K110862
    Device Name
    VAPRO PLUS INTERMITTENT CATHETER
    Manufacturer
    HOLLISTER, INCORPORATED
    Date Cleared
    2011-04-26

    (28 days)

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

    HOLLISTER, INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The VaPro Plus intermittent catheter is a flexible tubular device that is inserted through the urethra by male, female and pediatric patients who need to drain urine from the bladder.
    Device Description
    The VaPro Plus intermittent catheter is a hydrophilic coated single use catheter to be used as a means of managing urinary incontinence by draining urine from the bladder. The catheter comes in a protective sleeve and is offered with a protective introducer tip as a way to shield the sterile catheter from bacteria in the distal urethra during insertion. The packaging contains a vapor strip that hydrates the catheter coating which then lubricates the catheter. The outer packaging was designed to facilitate access for those with limited dexterity. The catheter is connected to a collection bag for use when drainage into a suitable receptacle is not feasible or practical.
    Ask a Question

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