Bard RiteCath Intermittent Urinary Catheter

Catheter, Straight

C.R. Bard, Inc.

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

Pre-market Notification Details

Device IDK142575
510k NumberK142575
Device Name:Bard RiteCath Intermittent Urinary Catheter
ClassificationCatheter, Straight
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 CodeEZD  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-12
Decision Date2014-10-31
Summary:summary

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