DQX · Class II · 21 CFR 870.1330

FDA Product Code DQX: Wire, Guide, Catheter

FDA product code DQX covers catheter guidewires used in intravascular procedures.

These thin, flexible wires are inserted into blood vessels to guide catheters, sheaths, and other devices to their target location. They are available in a wide range of diameters, stiffness profiles, and tip shapes optimized for different anatomical access points and clinical applications.

DQX devices are Class II medical devices, regulated under 21 CFR 870.1330 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..

764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
49–72 of 764
Cleared May 17, 2022
Medline Integrated Arterial Catheter
K210548
Centurion Medical Products
Cardiovascular · 446d
Cleared Apr 19, 2022
Spartan Center Wire
K220075
Spartan Micro, Inc.
Cardiovascular · 99d
Cleared Mar 18, 2022
Cardio Flow Peripheral Guide Wire
K213834
Cardio Flow Inc.,
Cardiovascular · 99d
Cleared Feb 17, 2022
Lunderquist Extra Stiff Wire Guide
K220137
William Cook Europe Aps
Cardiovascular · 30d
Cleared Feb 09, 2022
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
K212167
Vascular Solutions, LLC
Cardiovascular · 212d
Cleared Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Nov 22, 2021
Pre-Formed Extra Support Guidewire
K211741
Lake Region Medical
Cardiovascular · 168d
Cleared May 04, 2021
VASSALLO GT Hybrid
K203529
Filmecc Co., Ltd.
Cardiovascular · 153d
Cleared Apr 21, 2021
VASSALLO GT
K203533
Filmecc Co., Ltd.
Cardiovascular · 140d
Cleared Apr 15, 2021
Verrata PLUS Pressure Guide Wire
K210235
Volcano Corporation
Cardiovascular · 77d
Cleared Feb 18, 2021
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
K201720
Beijing Bywave Sensing Medical Technology Co., Ltd.
Cardiovascular · 240d
Cleared Oct 14, 2020
Merit Hydrophilic Guide Wire
K201595
Merit Medical Systems, Inc.
Cardiovascular · 124d
Cleared Sep 28, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K202543
Volcano Corporation
Cardiovascular · 26d
Cleared Aug 26, 2020
Hydrophilic Coating Guide Wire
K193653
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular · 240d
Cleared Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
K201834
Abbott Vascular
Cardiovascular · 28d
Cleared Jul 29, 2020
Zoom 14 Guidewire
K201760
Scientia Vascular, LLC
Neurology · 30d
Cleared Jul 21, 2020
Mirage Hydrophilic Guidewire
K201690
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared May 07, 2020
LiteSaber Wire Torque Assist Device
K200120
Vesatek, LLC
Cardiovascular · 107d
Cleared Apr 08, 2020
Go2Wire Guide Wire
K193571
Merit Medical System, Inc.
Cardiovascular · 107d
Cleared Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
K200144
Abbott Vascular
Cardiovascular · 77d
Cleared Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
K192886
Volcano Corporation
Cardiovascular · 168d
Cleared Jan 18, 2020
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
K193548
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology · 29d
Cleared Jan 15, 2020
Wattson Temporary Pacing Guidewire
K192454
Vascular Solutions
Cardiovascular · 128d
Cleared Jan 02, 2020
OptoWire III
K191907
Opsens, Inc.
Cardiovascular · 170d