ANGIOLAPCATH CHOLANGIOGRAPHY KIT

Catheter, Cholangiography

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Angiolapcath Cholangiography Kit.

Pre-market Notification Details

Device IDK926143
510k NumberK926143
Device Name:ANGIOLAPCATH CHOLANGIOGRAPHY KIT
ClassificationCatheter, Cholangiography
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactMarcia C Leatham
CorrespondentMarcia C Leatham
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-12-07
Decision Date1993-07-07

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