CLARUS CHOLANGIOGRAM CATHETER KIT

Catheter, Cholangiography

CLARUS MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Cholangiogram Catheter Kit.

Pre-market Notification Details

Device IDK925742
510k NumberK925742
Device Name:CLARUS CHOLANGIOGRAM CATHETER KIT
ClassificationCatheter, Cholangiography
Applicant CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis,  MN  55447
ContactGregory J Mathison
CorrespondentGregory J Mathison
CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis,  MN  55447
Product CodeGBZ  
CFR Regulation Number878.4200 [🔎]
DecisionSubstantially Equivalent - Kit (SESK)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-13
Decision Date1993-06-01

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