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
Cleared
May 17, 2022
Medline Integrated Arterial Catheter
Centurion Medical Products
Cardiovascular
446d
Cleared
Apr 19, 2022
Spartan Center Wire
Spartan Micro, Inc.
Cardiovascular
99d
Cleared
Mar 18, 2022
Cardio Flow Peripheral Guide Wire
Cardio Flow Inc.,
Cardiovascular
99d
Cleared
Feb 17, 2022
Lunderquist Extra Stiff Wire Guide
William Cook Europe Aps
Cardiovascular
30d
Cleared
Feb 09, 2022
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
Vascular Solutions, LLC
Cardiovascular
212d
Cleared
Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
Asahi Intecc Co., Ltd.
Cardiovascular
170d
Cleared
Nov 22, 2021
Pre-Formed Extra Support Guidewire
Lake Region Medical
Cardiovascular
168d
Cleared
May 04, 2021
VASSALLO GT Hybrid
Filmecc Co., Ltd.
Cardiovascular
153d
Cleared
Apr 21, 2021
VASSALLO GT
Filmecc Co., Ltd.
Cardiovascular
140d
Cleared
Apr 15, 2021
Verrata PLUS Pressure Guide Wire
Volcano Corporation
Cardiovascular
77d
Cleared
Feb 18, 2021
LiPPS Analyzer, LiPPS Wire Pressure Guide Wire
Beijing Bywave Sensing Medical Technology Co., Ltd.
Cardiovascular
240d
Cleared
Oct 14, 2020
Merit Hydrophilic Guide Wire
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
Volcano Corporation
Cardiovascular
26d
Cleared
Aug 26, 2020
Hydrophilic Coating Guide Wire
Suzhou Hengrui Disheng Medical Co., Ltd.
Cardiovascular
240d
Cleared
Jul 30, 2020
HI-TORQUE PROCEED Guide Wire Family
Abbott Vascular
Cardiovascular
28d
Cleared
Jul 29, 2020
Zoom 14 Guidewire
Scientia Vascular, LLC
Neurology
30d
Cleared
Jul 21, 2020
Mirage Hydrophilic Guidewire
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
29d
Cleared
May 07, 2020
LiteSaber Wire Torque Assist Device
Vesatek, LLC
Cardiovascular
107d
Cleared
Apr 08, 2020
Go2Wire Guide Wire
Merit Medical System, Inc.
Cardiovascular
107d
Cleared
Apr 08, 2020
HI-TORQUE Steelcore Bare Guide Wire
Abbott Vascular
Cardiovascular
77d
Cleared
Mar 26, 2020
OmniWire Pressure Guide Wire, 185 cm Straight Tip, OmniWire Pressure Guide Wire, 185 cm J-Tip
Volcano Corporation
Cardiovascular
168d
Cleared
Jan 18, 2020
Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Neurology
29d
Cleared
Jan 15, 2020
Wattson Temporary Pacing Guidewire
Vascular Solutions
Cardiovascular
128d
Cleared
Jan 02, 2020
OptoWire III
Opsens, Inc.
Cardiovascular
170d