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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name stents, drains and dilators for the biliary ducts
510(k) Number K151925
Device Name Elation Wireguided Balloon Dilation Catheter
Applicant
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PARKWAY
SOUTH JORDAN,  UT  84095
Applicant Contact DAVID THOMAS
Correspondent
MERIT MEDICAL SYSTEMS, INC.
1600 WEST MERIT PARKWAY
SOUTH JORDAN,  UT  84095
Correspondent Contact DAVID THOMAS
Regulation Number876.5010
Classification Product Code
FGE  
Date Received07/13/2015
Decision Date 11/06/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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