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510(k) Data Aggregation
K Number
K233013Device Name
2-Way 100% Silicone Cleartract Catheter
Manufacturer
Silq Technologies Corporation
Date Cleared
2024-01-23
(123 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Silq Technologies Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder, but also suprapubic placement or by nephrostomy. Intended population is adults and pediatrics.
Device Description
The 2-Way 100% Silicone ClearTract Catheter is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection between the catheter and the urinary bag is accomplished by using a standard non- interconnector. Catheterization is accomplished by inserting the catheter through the urethra. Drainage can also be accomplished by suprapubic placement or nephrostomy tract placement of the catheter.
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K Number
K221625Device Name
2-Way 100% Silicone ClearTract Catheter
Manufacturer
Silq Technologies Corporation
Date Cleared
2022-07-01
(25 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Silq Technologies Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 2-Way 100% Silicone ClearTract Catheter is intended for drainage of the urinary tract. Catheterization is accomplished by inserting the catheter through the urethra and into the bladder. Intended population is adults and pediatrics.
Device Description
The 2-Way 100% Silicone ClearTract Catheter (previously known as the HDX 100% Silicone 2-Way Foley Catheter) is a standard single-use 2-way Foley catheter that is constructed of medical grade silicone with a surface modification. It incorporates two (2) lumens, one for inflation/deflation of the balloon and the other for drainage of the urinary tract. The drainage inlet is located distal to the catheter's balloon. The connection to the urinary bag is a standard non-interconnectable connector.
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