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510(k) K023300

HI-TORQUE WHISPER LS; HI-TORQUE WHISPER MS; HI-TORQUE WHISPER MS CS-J; HI-TORQUE WHISPER ES; HI-TORQUE WHISPER ES CS-J by Guidant Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 28, 2002
Date Received
October 3, 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

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)
  • K033393 — ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (November 10, 2003)
  • 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)

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