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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 K032530
Device Name MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM
Applicant
Guidant Corporation
1525 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact MICHELLE GROSSMAN
Correspondent
Guidant Corporation
1525 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact MICHELLE GROSSMAN
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/15/2003
Decision Date 10/23/2003
Decision SE - With Limitations (SESU)
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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