Home / 510(k) Clearances / K152709

510(k) K152709

HI-TORQUE BALANCE by Abbott Vascular — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2015
Date Received
September 21, 2015
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 Abbott Vascular

  • K220634 — NC TREK NEO Coronary Dilatation Catheter (June 30, 2022)
  • K221057 — Viatrac 14 Plus Peripheral Dilatation Catheter (May 5, 2022)
  • K201834 — HI-TORQUE PROCEED Guide Wire Family (July 30, 2020)
  • K200144 — HI-TORQUE Steelcore Bare Guide Wire (April 8, 2020)
  • K193126 — HI-TORQUE InfilTrac Guide Wire Family (December 11, 2019)
  • K191173 — Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery Wires (July 25, 2019)
  • K180040 — NC TREK™ RX Coronary Dilatation Catheter; NC TREK™ OTW Coronary Dilatation Cathe (August 24, 2018)
  • K173795 — HI-TORQUE TurnTrac Guide Wire Family (January 12, 2018)
  • K172394 — Steerable Guide Catheter (September 6, 2017)
  • K172073 — Hi-Torque Command 18 Guide Wire (August 25, 2017)

Other clearances for product code DQX

  • 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)
  • K250203 — SureAx-Guide™ (October 17, 2025)
  • K250031 — Amplatzer Guidewire (October 3, 2025)
  • K251181 — Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5); Splashwire Hydrophilic Guid (August 29, 2025)
  • K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire (July 25, 2025)
  • K250075 — Medtronic Stedi Extra Support Guidewire (June 13, 2025)