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510(k) K030019

MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE by Guidant Corp. — Product Code DQX

K030019 is an FDA 510(k) premarket notification submitted by Guidant Corp. for the device "MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE". The FDA issued a decision of Substantially Equivalent on January 24, 2003. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Guidant Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2003
Date Received
January 3, 2003
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.

  • K061865 — FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (July 27, 2006)
  • K061453 — HI-TORQUE WHISPER VIEW GUIDE WIRE (June 22, 2006)
  • 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)

Other clearances for product code DQX

  • K253667 — Accoat Guide Wire (July 14, 2026)
  • K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire (July 13, 2026)
  • K254137 — InQwire Amplatz Guide Wire (May 22, 2026)
  • K260544 — FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40 (March 20, 2026)
  • K253746 — Enroute 0.014'' Transcarotid Guidewire (March 19, 2026)
  • K253262 — EmeryGlide™ (EG18008901) (March 6, 2026)
  • K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) (January 31, 2026)
  • K251385 — InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQ (January 21, 2026)
  • K252674 — Solo Pace Fusion System (SOLOFUSE1) (January 9, 2026)
  • K251596 — Lunderquist Extra Stiff Wire Guide (November 9, 2025)

FDA data resources