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Found 4 results
510(k) Data Aggregation
K Number
K132500Device 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
876.5130Why 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
K110653Device Name
CURE CATHETER
Manufacturer
CURE MEDICAL LLC.
Date Cleared
2011-08-01
(147 days)
Product Code
EZD
Regulation Number
876.5130Why 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
K080881Device Name
CURE CATHETER CLOSED SYSTEM
Manufacturer
CURE MEDICAL LLC.
Date Cleared
2008-06-11
(72 days)
Product Code
KOD
Regulation Number
876.5130Why 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
K072539Device Name
CURE CATHETER
Manufacturer
CURE MEDICAL LLC.
Date Cleared
2007-09-13
(3 days)
Product Code
EZD
Regulation Number
876.5130Why 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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