RESOLVE BILIARY LOCKING 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 Locking Drainage Catheter.

Pre-market Notification Details

Device IDK141408
510k NumberK141408
Device Name:RESOLVE BILIARY LOCKING DRAINAGE CATHETER
ClassificationStents, Drains And Dilators For The Biliary Ducts
Applicant MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan,  UT  84095
ContactGlen Norton
CorrespondentGlenn Norton
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 Received2014-05-28
Decision Date2014-11-26
Summary:summary

NIH GUDID Devices

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