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510(k) K041762

FINISHING WIRE SUPPORTRAK by Guidant Corporation — Product Code DQX

K041762 is an FDA 510(k) premarket notification submitted by Guidant Corporation for the device "FINISHING WIRE SUPPORTRAK". The FDA issued a decision of Substantially Equivalent on August 6, 2004. The device falls under product code DQX (Wire, Guide, Catheter), a Class II device regulated under 21 CFR 870.1330. Guidant Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 6, 2004
Date Received
June 30, 2004
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

Other clearances by Guidant Corporation

  • K060449 — HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE (May 30, 2006)
  • K053459 — OMNILINK .035 BILIARY STENT SYSTEM (April 12, 2006)
  • K053454 — RX HERCULINK ELITE BILIARY STENT SYSTEM (March 6, 2006)
  • K053019 — ACUITY STEERABLE STYLET ACCESSORY (March 3, 2006)
  • K052965 — EASYTRAK 2 STYLET, MODELS 4826, 4829, 4832. (February 13, 2006)
  • 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)
  • K041574 — CPI LEAD ADAPTERS, MODELS 6017, 6018 AND 6020 (July 12, 2004)

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