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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 K011806
Device Name PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
Applicant
Sulzer Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Applicant Contact MARIA E BRITTLE
Correspondent
Sulzer Intratherapeutics, Inc.
651 Campus Dr.
Saint Paul,  MN  55112
Correspondent Contact MARIA E BRITTLE
Regulation Number876.5010
Classification Product Code
FGE  
Date Received06/11/2001
Decision Date 09/07/2001
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
Recalls CDRH Recalls
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