Product code DQX— Cardiovascular
CORDIS STEERABLE GUIDEWIRE
- Classification name
- Wire, Guide, Catheter
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Total cleared
- 767
- First cleared
- Most recent
Market context for product code DQX
FDA has cleared devices under product code DQX between 1976 and 2026, filed by 214 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2024
- 2023
- 2022
- 2021
- 2020
- 2019
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
Top applicants under product code DQX
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DQX
1–100 of 767- K261281 — CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
- K253667 — Accoat Guide Wire
- K261640 — Merit MAK Nitinol/Gold-Tungsten Guide Wire
- K254137 — InQwire Amplatz Guide Wire
- K260544 — FMD Peripheral Guide Wire F-14 Flex 6 +4 more
- K253746 — Enroute 0.014'' Transcarotid Guidewire
- K253262 — EmeryGlide (EG18008901)
- K253847 — Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
- K251385 — InQwire Super Stiff Guide Wire (6 models)
- K252674 — Solo Pace Fusion System (SOLOFUSE1)
- K251596 — Lunderquist Extra Stiff Wire Guide
- K250203 — SureAx-Guide
- K250031 — Amplatzer Guidewire
- K251181 — Splashwire Hydrophilic Guide Wire (6 models)
- K250552 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K250075 — Medtronic Stedi Extra Support Guidewire
- K243733 — SION blue PLUS
- K241962 — Crossloop
- K242597 — CROSSLEAD 0.018inch
- K241702 — CROSSLEAD 0.014inch
- K241521 — Prelude Small O.D. Introducer Guide Wire
- K242824 — PTFE Guidewire
- K240818 — R2P Radifocus Glidewire Advantage
- K240997 — Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
- K241784 — Arrow® Nitinol Wire
- K240859 — Glidewire GT-R
- K241510 — CROSSLEAD Tracker
- K240387 — MINAMO blue; MINAMO viola
- K240460 — FMD Peripheral Guide Wire F-18 Flex 400 (CSU415400259)
- K240864 — PacePro Wire
- K232662 — BNLE Hydrophilic Jacketed Peripheral Guidewire
- K230418 — Mighty Wire Guide Wire
- K232570 — Steerant Super Stiff Guidewire
- K232574 — VASSALLO GT Crossing14
- K232578 — VASSALLO GT 018 G12; VASSALLO GT 018 G30
- K230377 — CROSSLEAD Penetration Peripheral Guide Wire
- K223791 — TalWire
- K230637 — Wattson temporary pacing guidewire (2250)
- K221390 — BNLE Access Guidewire
- K223432 — Vassallo GT 018 Hybrid
- K213898 — ProTrack Pigtail Wire
- K221351 — Mechanical Guidewire
- K222631 — VASSALLO GT EXT
- K221575 — Pre-Formed Blue
- K212615 — EpiFaith CV
- K213854 — SavvyWire
- K213868 — ASAHI Gladius Mongo18 PV ES
- K221917 — Stent Positioning Assistance System (SPAS)
- K213315 — CROSSLEAD Peripheral Guide Wire
- K213949 — VASSALLO GT 018 Floppy
- K212268 — FMD Peripheral Guide Wires F-14 and F-18, FMD Guide Wire Extension F-14 EXT
- K210548 — Medline Integrated Arterial Catheter
- K220075 — Spartan Center Wire
- K213834 — Cardio Flow Peripheral Guide Wire
- K220137 — Lunderquist Extra Stiff Wire Guide
- K212167 — R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
- K211898 — ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
- K211741 — Pre-Formed Extra Support Guidewire
- K203529 — VASSALLO GT Hybrid
- K203533 — VASSALLO GT
- K210235 — Verrata PLUS Pressure Guide Wire
- K201720 — LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
- K201595 — Merit Hydrophilic Guide Wire
- K202543 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K193653 — Hydrophilic Coating Guide Wire
- K201834 — HI-TORQUE PROCEED Guide Wire Family
- K201760 — Zoom 14 Guidewire
- K201690 — Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
- K200120 — LiteSaber Wire Torque Assist Device
- K193571 — Go2Wire Guide Wire
- K200144 — HI-TORQUE Steelcore Bare Guide Wire
- K192886 — OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
- K193548 — Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
- K192454 — Wattson Temporary Pacing Guidewire
- K191907 — OptoWire III
- K192599 — ASAHI PTCA Guide Wire ASAHI Gaia Next
- K193194 — CrossTorq 14 Guidewire
- K193126 — HI-TORQUE InfilTrac Guide Wire Family
- K191502 — Heraeus Peripheral Guidewire
- K191464 — Asahi PTCA Guide Wire Asahi SION Series
- K192783 — Aristotle 24 Guidewire, 200cm, Soft Profile +2 more
- K191687 — pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
- K190176 — MINAMO
- K182985 — Roadrunner PC Wire Guide, Olcott Torque Device
- K183062 — ASAHI Silverway
- K182457 — Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
- K182553 — Inno-Pathwire
- K181353 — Lunderquist® Fixed Core Wire Guide
- K183467 — Roadrunner Extra Support Wire Guide
- K180830 — Reuter Tip Deflecting Wire Guide
- K182315 — Magic Torque DLVR Guidewire
- K181647 — Bandit guidewire
- K180784 — ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
- K173277 — ASAHI PTCA Guide Wire ASAHI SION black
- K180726 — Savion DLVR Guidewire, Savion FLX Guidewire
- K181351 — Double Flexible Tipped Wire Guides
- K181001 — Medtronic Confida Brecker Guidewire
- K180795 — JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
- K172187 — Inno-Hydrowire
- K171997 — Mandril Wire Guide
Data sourced from openFDA. This site is unofficial and independent of the FDA.