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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 K170743
Device Name AngioDynamics Total Abscession Biliary Drainage Catheter
Applicant
AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury,  NY  12804
Applicant Contact Teri Juckett
Correspondent
AngioDynamics, Inc.
603 Queensbury Avenue
Queensbury,  NY  12804
Correspondent Contact Teri Juckett
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/10/2017
Decision Date 03/30/2017
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
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