BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS

Catheter, Double Lumen Female Urethrographic

C.R. BARD, INC.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Hydrogel-coated Diagnostic Urethral Catheters.

Pre-market Notification Details

Device IDK910196
510k NumberK910196
Device Name:BARD HYDROGEL-COATED DIAGNOSTIC URETHRAL CATHETERS
ClassificationCatheter, Double Lumen Female Urethrographic
Applicant C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
ContactDonna J Wilson
CorrespondentDonna J Wilson
C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington,  GA  30014
Product CodeFGH  
CFR Regulation Number876.5130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-01-16
Decision Date1991-03-27

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