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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 K072301
Device Name 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
Applicant
Ev3, Inc.
4600 Nathan Ln. N.
Plymouth,  MN  55442 -2920
Applicant Contact David Worrell
Correspondent
Ev3, Inc.
4600 Nathan Ln. N.
Plymouth,  MN  55442 -2920
Correspondent Contact David Worrell
Regulation Number876.5010
Classification Product Code
FGE  
Date Received08/17/2007
Decision Date 03/18/2008
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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