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510(k) Data Aggregation

    K Number
    K233094
    Device Name
    Wellead® Latex Foley Catheter
    Manufacturer
    Well Lead Medical (Hainan) Co., Ltd.
    Date Cleared
    2024-06-06

    (254 days)

    Product Code
    MJC, EYB, EZL
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Latex Foley Catheter is inserted into the bladder through urethra and are indicated for routine urine drainage or for routine post-operative drainage and bladder irrigation.
    Device Description
    The Latex Foley Catheter is inserted through the urethra during urinary catheterization and goes into the bladder for urine drainage or irrigation. It consists of a shaft, a drainage funnel, an inflation funnel, an irrigation funnel (if present), a balloon and a valve. The device is made from latex with silicone coating and available in different types (e.g., straight, Tiemann, female etc.) and sizes for adult and pediatric use.
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    K Number
    K040658
    Device Name
    BARDEX I.C. LATEX FOLEY CATHETER
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    2004-09-29

    (201 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bardex® I.C. latex Foley catheter is indicated for use in the drainage and/or collection, the The Dardes .. Online. Generally, drainage is accomplished by inserting the catheter through the urethra and into the bladder. However, drainage is sometimes calleter through the "drethra" and "into" the "bladen" "Hower, such as nephrostomy tract.
    Device Description
    The Bard® Bardex® I.C. latex Foley catheter is a two-way Foley catheter which is placed in the bladder through the urethra. The balloon on the distal end of the catheter is inflated with sterile water after insertion and used to secure the catheter in place and ensure that the opening in the distal tip of the catheter is positioned correctly to allow for urine drainage. The urine drains out through the catheter into a collection device attached to the catheter.
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    K Number
    K033477
    Device Name
    HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Date Cleared
    2004-06-10

    (220 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hydrophilic-Antibacterial Intermittent Catheter is intended for urological use only. The Hydrophilic-Antibacterial Intermittent Catheter is intended for urinary bladder drainage in the management of incontinence, neurogenic bladder dysfunction, and surgical procedures in adult males and females requiring catheterization. Efficacy of the Hydrophilic-Antibacterial Intermittent Catheter in preventing urinary tract infection during intermittent use has not been shown. It is not intended as a treatment for active urinary tract infection. Intermittent Catheter Closed System Kit is intended for use by patients for the purpose of bladder drainage.
    Device Description
    The Hydrophilic-Antibacterial Intermittent Catheter consists of a hydrophilic and antibacterial coated single lumen catheter with either two or four drainage eyes on the proximal tip. It is constructed from medical grade elastomers. The Intermittent Catheter Closed System Kit consists of a single lumen urethral catheter (Hydrophilic-Antibacterial Intermittent Catheter, Hydrophilic Personal® Catheter K000723, or Antibacterial Personal® Catheter K001143) in a closed system-in-a-bag configuration with an introducer tip and insertion supplies.
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    K Number
    K000251
    Device Name
    SPECTRUM SILICONE FOLEY CATHETER
    Manufacturer
    COOK UROLOGICAL, INC.
    Date Cleared
    2000-08-30

    (216 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K001143
    Device Name
    RELEASE NF ANTIBACTERIAL FOLEY CATHETER, ANTIBACTERIAL PERSONAL CATHETER
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Date Cleared
    2000-07-07

    (88 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K993464
    Device Name
    BARDEX I.C. PEDIATRIC FOLEY CATHETER
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1999-12-10

    (58 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bardex I. C. Pediatric Foley Catheter is intended 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.
    Device Description
    The Bardex I. C. Pediatric Foley Catheter is a two-way latex Foley catheter with silver and hydrogel coatings.
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    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?
    Product Code :

    MJC

    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
    K983101
    Device Name
    BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24
    Manufacturer
    C.R. BARD, INC.
    Date Cleared
    1998-11-03

    (61 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Bardex I. C. 4-Way Foley Catheter is indicated for use in bladder/urinary tract drainage/irrigation and to assist in hemostasis and surgical site drainage following procedures such as transurethral resection of the prostate.
    Device Description
    The Bardex I. C. 4-Way Foley Catheter is a new catheter design incorporating the addition of a fourth lumen for prostatic drainage and the addition of several prostatic drainage eyes proximal to the balloon.
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    K Number
    K971627
    Device Name
    SILICONE ANTIBACTERIAL FOLEY CATHETER
    Manufacturer
    ROCHESTER MEDICAL CORP.
    Date Cleared
    1998-01-13

    (256 days)

    Product Code
    MJC
    Regulation Number
    876.5130
    Why did this record match?
    Product Code :

    MJC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Silicone Antibacterial Foley Catheter is intended for short term use to provide continuous urinary bladder drainage in adult males and females requiring catheterization for surgical procedures, monitoring uring output, management of incontinence, and voiding dysfunction. The catheter has been shown to provide a statistically significant redution in the incidence of catheter acquired bacterial urinary tract infection during the first 5 days of catheterization. This device is not intended to be used as a treatment for active urinary tract infection.
    Device Description
    The catherer consists of a standard configuration Foley catheter with a drainage lumen that exits through two drainage eyes on the proximal end. A retention balloon is located near the proximal catheter tip. The retention balloon is filled thru a second lumen with a Luer valve that extends from a side arm on the distal end of the catherer to the balloon. The catherer is coated with nitrofurazone impregnated siliconc on the outside surface and inner lumen. It is available in 12, 18 and 20 Fr sizes. All French sizes are provided in a 16 inch length with a 5 or 10 cc size balloon.
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