Home / 510(k) Clearances / K142598

510(k) K142598

Opto Wire and OptoMonitor System by Opsens, Inc. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2015
Date Received
September 15, 2014
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 Opsens, Inc.

  • K251367 — OptoMonitor 3 (January 16, 2026)
  • K241418 — OptoMonitor 3 (February 12, 2025)
  • K240864 — PacePro Wire (May 24, 2024)
  • K213854 — SavvyWire (September 14, 2022)
  • K202943 — OptoMonitor 3 (November 24, 2020)
  • K193620 — OptoMonitor 3 (June 18, 2020)
  • K191907 — OptoWire III (January 2, 2020)
  • K192340 — OptoMonitor (December 12, 2019)
  • K161263 — OptoMonitor II (September 13, 2016)
  • K152991 — OptoWire Deux (February 11, 2016)

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)