Bard Vertus 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 Vertus Foley Catheter.

Pre-market Notification Details

Device IDK180781
510k NumberK180781
Device Name:Bard Vertus Foley Catheter
ClassificationCatheter, Retention Type, Balloon
Applicant C. R. Bard, Inc. 8195 Industrial Blvd. Covington,  GA  30014
ContactSharon Lambert
CorrespondentSharon Lambert
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 Received2018-03-26
Decision Date2018-09-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.