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510(k) Data Aggregation

    K Number
    K132500
    Device Name
    CURE CATHETER FEMALE, CURE CATHETER MALE, CURE CATHETER COUDE, CURE CATHETER PEDIATRIC, CURE CATHETER HYDROPHILIC COATED
    Manufacturer
    CURE MEDICAL LLC.
    Date Cleared
    2013-12-23

    (136 days)

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

    CURE MEDICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cure Catheter ® Hydrophilic Coated is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage. The urinary catheter comes in a variety of sizes, packaged sterile for single-use.
    Device Description
    The Cure Catheter ™ Hydrophilic Coated is an intermittent urinary catheter intended to be used by adult and pediatric males and females for the purpose of bladder drainage. The catheter is manufactured with conventional medical grade PVC. The surface is coated with a hydrophilic low-friction coating (polyvinyl pyrrolidone, or PVP) and, when activated with water it becomes slippery and ready to use. The straight and Coudè tip configurations have been designed to eliminate trauma to the urethra and are offered in a variety of sizes. Each catheter is provided in sterile, single-use packages.
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    K Number
    K110653
    Device Name
    CURE CATHETER
    Manufacturer
    CURE MEDICAL LLC.
    Date Cleared
    2011-08-01

    (147 days)

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

    CURE MEDICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    An intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for pediatric males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
    Device Description
    The Cure Pediatric Catheter device is an intermittent urinary catheter intended to be used by pediatric males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to open, sterile, single-use packages.
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    K Number
    K080881
    Device Name
    CURE CATHETER CLOSED SYSTEM
    Manufacturer
    CURE MEDICAL LLC.
    Date Cleared
    2008-06-11

    (72 days)

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

    CURE MEDICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
    Device Description
    The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag and intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.
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    K Number
    K072539
    Device Name
    CURE CATHETER
    Manufacturer
    CURE MEDICAL LLC.
    Date Cleared
    2007-09-13

    (3 days)

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

    CURE MEDICAL LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cure Catheter™ is an intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The unders catheter comes in a variety of sizes packaged sterile for single-use.
    Device Description
    The Cure Catheter™ device is an intermittent urinary catheter intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in easy-to-open, sterile, single-use packages.
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