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510(k) Data Aggregation
K Number
K230400Device Name
Cure Catheter Closed System; Cure Dextra Closed System
Manufacturer
ConvaTec, Inc.
Date Cleared
2023-11-08
(266 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ConvaTec, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cure Dextra® 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 and is packaged sterile for single-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 and is packaged sterile for single-use.
Device Description
The Cure Dextra® and Cure Catheter® Closed System catheters are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to minimize trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
The subject devices are pre-lubricated catheter systems that allow for patient convenience when catheterization is required. The Closed System catheter is attached to a collection bag and features polished eyelets on a straight or Coudé catheter tip. The Dextra catheter will advance from the bag with every forward stroke while the rearward strokes allow for the mechanism to get a new grip on the catheter. The urine collection bag of the Dextra catheter is reduced from 1500 ml in the predicate Closed System to 1000 ml to make it compact and portable.
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K Number
K221593Device Name
Cure Ultra Male, Cure Ultra Female, Cure Ultra Plus
Manufacturer
ConvaTec, Inc.
Date Cleared
2022-11-17
(168 days)
Product Code
EZD
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
ConvaTec, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cure Ultra® is an intermittent urinary catheter 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 and is packaged sterile for single-use.
Device Description
The Cure Ultra® catheters, which include the Cure Ultra® Male, Cure Ultra® Female and Cure Ultra® Plus products are intermittent urinary catheters intended to be used by males and females for the purpose of bladder drainage. They are manufactured with conventional medical grade, biocompatible materials that are not made with natural rubber latex. The tip has been designed to eliminate trauma to the urethra and is provided in various sizes in easy-to-open, sterile, single-use packages.
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