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510(k) Data Aggregation
K Number
K130908Device Name
DISPOSABLE SILICONE FOLEY CATHETER
Manufacturer
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
Date Cleared
2013-10-03
(185 days)
Product Code
EZL
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
GUANGDONG BAIHE MEDICAL TECHNOLOGY CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Two-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage for urological use only; the indwell time of the proposed device is no more than 30 days.
Three-way Disposable Silicone Foley Catheter: Urethral catheterization for bladder drainage and bladder irrigation for urological use only; the indwell time of the proposed device is no more than 30 days.
Device Description
The Disposable Silicone Foley Catheter is available in two types, two-way disposable silicone Foley catheter and three-way disposable silicone Foley catheter.
The two-way disposable silicone Foley catheter is composed of a double lumen tube, a double lumen hub, one balloon and a tip.
The three-way disposable silicone Foley catheter is composed of a triple lumen tube, a triple lumen hub, one balloon and a tip.
The proposed device is supplied in French size ranging from 6 to 26. It is available in 310mm and 400mm length with various balloon sizes. The devices are applied for male and female; the 6Fr, 8Fr and 10Fr catheters are for pediatric, and others are for adult.
The Disposable Silicone Foley Catheter is provided EO sterilized as a single used device.
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