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510(k) Data Aggregation
K Number
K024010Device Name
DOVER SILVER HYDROGEL COATED SILICONE FOLEY CATHETER
Manufacturer
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
Date Cleared
2003-06-11
(189 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
THE KENDALL COMPANY DIV. OF TYCO HEALTHCARE GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The proposed device 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 Kendall DOVER Silver Hydrogel Coated Silicone Foley Catheter is a sterile, single patient use, urinary drainage catheter extruded from 100% vulcanized silicone material. It is coated with a lubricious hydrophilic topcoat containing an inorganic silver releasing polymer.
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