Home / 510(k) Clearances / K111288

510(k) K111288

ANCHORWIRE GUIDEWIRE by Lake Region Medical — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2011
Date Received
May 6, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Lake Region Medical

  • K242824 — PTFE Guidewire (December 6, 2024)
  • K221575 — Pre-Formed Blue (October 7, 2022)
  • K211741 — Pre-Formed Extra Support Guidewire (November 22, 2021)
  • K160643 — ENROUTE 0.014 Guidewire (October 18, 2016)
  • K151244 — Pre-Formed Guidewire (June 11, 2015)
  • K140536 — HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT (December 17, 2014)
  • K142393 — PREDICATE III GUIDEWIRE (November 25, 2014)
  • K142397 — Predicate III Guidewire (September 19, 2014)
  • K140482 — MANDREL GUIDEWIRE (April 8, 2014)
  • K133155 — HYDROPHILIC COATED GUIDEWIRE (April 7, 2014)

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)