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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 K021824
Device Name DYNALINK .035 BILIARY SELF-EXPANDING STENT SYSTEM, MODELS 1010102-38,1010102-56,1010102-80,1010103-38,1010103-56, 101010
Applicant
Guidant Corp.
1525 O'Brien Dr.
Menlo Park,  CA  94025
Applicant Contact MARTHA MURARI
Correspondent
Guidant Corp.
1525 O'Brien Dr.
Menlo Park,  CA  94025
Correspondent Contact MARTHA MURARI
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/04/2002
Decision Date 07/02/2002
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
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