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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 K040413
Device Name CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM
Applicant
Cordis Europa, N.V.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact KAREN WILK
Correspondent
Cordis Europa, N.V.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact KAREN WILK
Regulation Number876.5010
Classification Product Code
FGE  
Date Received02/18/2004
Decision Date 06/21/2004
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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