Silicone Foley Catheter

Catheter, Retention Type, Balloon

Biosensors International Pte Ltd

The following data is part of a premarket notification filed by Biosensors International Pte Ltd with the FDA for Silicone Foley Catheter.

Pre-market Notification Details

Device IDK182463
501k NumberK182463
Device Name:Silicone Foley Catheter
ClassificationCatheter, Retention Type, Balloon
Applicant Biosensors International Pte Ltd 36 Jalan Tukang Singapore,  SG 619266
ContactLor Yen Yin
CorrespondentJane Chen
Biosensors International Pte Ltd 36 Jalan Tukang Singapore,  SG 619266
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGastroenterology/Urology
501k Review PanelGastroenterology/Urology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-10
Decision Date2019-11-06

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