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510(k) Data Aggregation
K Number
K201776Device Name
Foley Balloon Catheter for Urology
Manufacturer
Date Cleared
2020-12-30
(184 days)
Product Code
Regulation Number
876.5130Why did this record match?
Applicant Name (Manufacturer) :
Apollon co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Two-way and Three-way Disposable Silicone Foley Catheters are indicated for urethral catheterization for bladder drainage for urological use only. The Two-way Disposable Silicone Foley Catheters have an indwell time of no more than 30 days and are indicated for adult use only.
Device Description
This product is a Foley Balloon Catheter. It is a 'prescription only' device. It consists of a Manifold part and Shaft parts. The Manifold Part is equipped with a non-return valve for inflating the balloon and a band to fix the non-return valve and identify the catheter's size by its color. The Shaft parts have an x-ray opaque line for checking the position of the catheter by X-ray and a balloon to place the catheter in the bladder. After the catheter is inserted, distilled water or saline is injected to expand the balloon and fix the catheter in place. The shaft also contains drainage eyes for urine drainage, and a rounded tip to aid insertion of the catheter. This Foley Balloon Catheter will be provided in Two and Three-Way configurations. The Three-Way configuration contains an 'Irrigation Manifold' for washing the bladder with saline solution. The shaft and balloon of the catheter are made of silicone and zinc oxide. The tip and the manifold are made of silicone only. The proposed device is supplied in French sizes ranging from 12 to 24. It is available in 337(±15) mm and 345(±15) mm lengths with various balloon sizes. The devices for adults only.
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