RESOLVE BILIARY DRAINAGE CATHETER

Stents, Drains And Dilators For The Biliary Ducts

MERIT MEDICAL SYSTEMS, INC.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Resolve Biliary Drainage Catheter.

Pre-market Notification Details

Device IDK063733
510k NumberK063733
Device Name:RESOLVE BILIARY DRAINAGE CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactAmy Mckinney
CorrespondentAmy Mckinney
MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
Product CodeFGE  
CFR Regulation Number876.5010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-12-18
Decision Date2007-11-14
Summary:summary

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