Home / 510(k) Clearances / K240818

510(k) K240818

R2P Radifocus Glidewire Advantage by Terumo Corporation — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2024
Date Received
March 25, 2024
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 Terumo Corporation

  • K250700 — Pen Injector Needle 32.5 (November 21, 2025)
  • K250751 — DualView Catheter (July 17, 2025)
  • K240859 — Glidewire GT-R (August 21, 2024)
  • K190427 — Immucise (July 18, 2019)
  • K181369 — Immucise Intradermal Injection System (November 13, 2018)
  • K173799 — NaviCross 0.018 (March 29, 2018)
  • K170417 — Glidewire GT (September 15, 2017)
  • K130493 — CAPIOX RX05 HOLLOW FIBER OXYGENATOR/RESERVOIR (March 13, 2013)
  • K130280 — CAPIOX FX HOLLOW FIBER OXYGENATOR W/ RESERVOIR (March 13, 2013)
  • K122544 — TERUMO SURFLASH SAFETY I.V. CATHETER (September 5, 2012)

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)