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510(k) Data Aggregation

    K Number
    K984136
    Device Name
    BARDEX LUBRI-SIL I.C. FOLEY CATHETER
    Manufacturer
    BARD MEDICAL DIV.
    Date Cleared
    1999-02-16

    (90 days)

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

    BARD MEDICAL DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bardex® Lubri-Sil™ I.C. Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract. Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
    Device Description
    The Bardex® Lubri-Sil™ I.C. Foley Catheter is a two-way all-silicone Foley catheter with silver and lubricious hydrophilic coatings. The Bard Lubri-Sil I. C. Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a twolumen catheter with a drainage lumen and an inflation lumen with two-way valve. A silver coating and then a hydrophilic polymeric coating are applied to the finished catheter. The hydrophilic coating becomes very slippery when wet. The silver coating discourages bacterial adhesion to the catheter surface. The Lubri-Sil I.C. Foley Catheter is available in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.
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    K Number
    K984084
    Device Name
    BARDEX LUBRI-SIL FOLEY CATHETER
    Manufacturer
    BARD MEDICAL DIV.
    Date Cleared
    1999-02-01

    (77 days)

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

    BARD MEDICAL DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bardex® Lubri-Sil™ Foley Catheter is indicated for use in the drainage and/or collection and/or measurement of urine. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes accomplished by suprapubic or other placement of the catheter, such as a nephrostomy tract. Some Foley catheters, especially those with larger (30cc) balloons are used to assist in hemostasis following surgery such as transurethral resection of the prostate.
    Device Description
    The Bardex® Lubri-Sil™ Foley Catheter is a two-way all-silicone Foley catheter with a lubricious hydrophilic coating. The Bard Lubri-Sil Foley Catheter is constructed of high grade extruded clear silicone rubber with a molded tip and funnel. It is a two-lumen catheter with a drainage lumen and an inflation lumen with two-way valve. A hydrophilic polymeric coating is applied to the finished catheter. This coating becomes very slippery when wet. The Lubri-Sil Foley Catheter is available in shaft sizes 8 and 10 Fr. with a 3cc balloon, in even shaft sizes 12-24 Fr. with a 5cc balloon and in even shaft sizes 16-24 Fr. with a 30cc balloon.
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    K Number
    K970110
    Device Name
    BARD FLEXIBLE ENDOSCOPY INJECTION SYSTEM (651019)
    Manufacturer
    BARD MEDICAL DIV.
    Date Cleared
    1997-02-19

    (37 days)

    Product Code
    ODC
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    BARD MEDICAL DIV.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bard® Flexible Endoscopy Injection System is indicated as an accessory for currently available endoscopes to provide for delivery of injectable materials into tissues in the urinary bladder and lower urinary tract via percutaneous access through a pre-placed 20 Fr. (minimum) introducer. The system is designed for use with flexible endoscopes no larger than 18 Fr. and having a working channel accommodating 5 Fr. instrumentation.
    Device Description
    The Bard® Flexible Endoscopy Injection System consists of an endoscopic injection needle with an endoscopic working channel protector, a stainless steel endoscopic stabilizer sheath and optional medical tape for affixation purposes.
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