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510(k) K062798

SMART NITINOL SELF-EXPANDING STENT, MODEL C06120MB, C07120MB, C08120MB, C06150MB, C07150MB, C08150MB by Cordis Corp. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
February 6, 2008
Date Received
September 19, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stents, Drains And Dilators For The Biliary Ducts
Device Class
Class II
Regulation Number
876.5010
Review Panel
GU
Submission Type

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  • K033394 — CORDIS PALMAZ GENESIS TRANSHEPATIC BILLARY STENT ON OPTA PRO .035 DELIVERY SYSTE (December 22, 2003)
  • K032137 — PRECISE RX NITINOL STENT TRANSHEPATIC BILIARY SYSTEM (September 17, 2003)

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