BARD STONE REMOVAL BALLOON CATHETER

Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection

C.R. BARD, INC.

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

Pre-market Notification Details

Device IDK920342
510k NumberK920342
Device Name:BARD STONE REMOVAL BALLOON CATHETER
ClassificationBiliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
Applicant C.R. BARD, INC. ONE PARK WEST Tewksbury,  MA  01876 -1234
ContactJeanette Schier
CorrespondentJeanette Schier
C.R. BARD, INC. ONE PARK WEST Tewksbury,  MA  01876 -1234
Product CodeGCA  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-01-27
Decision Date1992-08-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20653405053801 K920342 000
20653405053795 K920342 000
20653405053788 K920342 000
20653405053771 K920342 000
20653405053764 K920342 000

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