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510(k) Data Aggregation
K Number
K141642Device Name
VAPRO INTERMITTENT CATHETER
Manufacturer
HOLLISTER, INCORPORATED
Date Cleared
2014-08-22
(64 days)
Product Code
GBM
Regulation Number
876.5130Why 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
K110862Device Name
VAPRO PLUS INTERMITTENT CATHETER
Manufacturer
HOLLISTER, INCORPORATED
Date Cleared
2011-04-26
(28 days)
Product Code
GBM
Regulation Number
876.5130Why 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.
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