Medline Silicone Foley Catheter

Catheter, Retention Type, Balloon

MEDLINE INDUSTRIES, INC.

The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Silicone Foley Catheter.

Pre-market Notification Details

Device IDK142635
510k NumberK142635
Device Name:Medline Silicone Foley Catheter
ClassificationCatheter, Retention Type, Balloon
Applicant MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein,  IL  60060
ContactMatt Clausen
CorrespondentMatt Clausen
MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein,  IL  60060
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-17
Decision Date2015-01-09
Summary:summary

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