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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 K990867
Device Name RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95052
Applicant Contact SANDRA SUNDELL
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
Santa Clara,  CA  95052
Correspondent Contact SANDRA SUNDELL
Regulation Number876.5010
Classification Product Code
FGE  
Date Received03/16/1999
Decision Date 09/02/1999
Decision SE - With Limitations (SESU)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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