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510(k) K021228

HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE by Guidant Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2002
Date Received
April 18, 2002
Clearance Type
Special
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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  • 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)

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