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510(k) K053454

RX HERCULINK ELITE BILIARY STENT SYSTEM by Guidant Corporation — Product Code FGE

Clearance Details

Decision
SESU ()
Decision Date
March 6, 2006
Date Received
December 9, 2005
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

Other clearances by Guidant Corporation

  • K060449 — HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (May 30, 2006)
  • K053459 — OMNILINK .035 BILIARY STENT SYSTEM (April 12, 2006)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • K052274 — GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 (September 21, 2005)
  • K052166 — MODIFICATION TO: RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 18, 2005)
  • K052165 — RX ACCUNET EMBOLIC PROTECTION SYSTEM (August 16, 2005)
  • K041981 — GUIDANT VASOVIEW 6 HARVESTING CANNULA, MODEL VH-2000; GUIDANT VASOVIEW 6 ACCESSO (August 20, 2004)
  • K041762 — FINISHING WIRE SUPPORTRAK (August 6, 2004)
  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)

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