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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 K053459
Device Name OMNILINK .035 BILIARY STENT SYSTEM
Applicant
Guidant Corporation
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact SYLVIA HERNANDEZ
Correspondent
Guidant Corporation
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact SYLVIA HERNANDEZ
Regulation Number876.5010
Classification Product Code
FGE  
Date Received12/13/2005
Decision Date 04/12/2006
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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