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510(k) K033393

ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM by Guidant Corp. — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
November 10, 2003
Date Received
October 23, 2003
Clearance Type
Special
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

Other clearances by Guidant Corp.

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  • K042908 — RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (November 12, 2004)
  • K042218 — ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 31, 2004)
  • K033834 — OMNILINK .018 BILIARY STENT SYSTEM (January 2, 2004)
  • K031678 — HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (August 26, 2003)
  • K031459 — RAPIDO CUT-AWAY CUTTER (July 23, 2003)
  • K031398 — IS-1 HEMOSTASIS VALVE, MODEL 6799 (May 20, 2003)
  • K030512 — GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM (May 14, 2003)
  • K030019 — MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE (January 24, 2003)

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  • K242845 — EGIS Biliary Double Bare Stent (BDB080405) (June 25, 2025)
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