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510(k) K052965

EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. by Guidant Corporation — Product Code DRB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2006
Date Received
October 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stylet, Catheter
Device Class
Class II
Regulation Number
870.1380
Review Panel
CV
Submission Type

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  • 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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  • K080924 — MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 (April 30, 2008)
  • K072864 — ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM (March 13, 2008)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K043401 — SPECTRANETICS LLD CS, MODEL 518-039 (March 16, 2005)