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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 K121832
Device Name RESOLVE BILIARY LOCKING DRAINAGE CATHETER
Applicant
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Applicant Contact CASEY HUGHES
Correspondent
Merit Medical Systems, Inc.
1111 S. Velasco St.
Angleton,  TX  77515
Correspondent Contact CASEY HUGHES
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/22/2012
Decision Date 07/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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