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510(k) K031678

HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING by Guidant Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 26, 2003
Date Received
May 30, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

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  • 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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