Bard LubriGuard Foley Catheter

Catheter, Retention Type, Balloon

C.R. Bard, Inc.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Lubriguard Foley Catheter.

Pre-market Notification Details

Device IDK150699
510k NumberK150699
Device Name:Bard LubriGuard Foley Catheter
ClassificationCatheter, Retention Type, Balloon
Applicant C.R. Bard, Inc. 8195 Industrial Blvd Covington,  GA  30014
ContactMichele Davis
CorrespondentMichele Davis
C.R. Bard, Inc. 8195 Industrial Blvd Covington,  GA  30014
Product CodeEZL  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-18
Decision Date2015-07-28
Summary:summary

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