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
Jan 02, 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
Asahi Intecc Co., Ltd.
Cardiovascular
104d
Cleared
Dec 13, 2019
CrossTorq 14 Guidewire
Scientia Cardio Access, LLC
Cardiovascular
24d
Cleared
Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
Abbott Vascular
Cardiovascular
29d
Cleared
Nov 26, 2019
Heraeus Peripheral Guidewire
Heraeus Medical Components, LLC
Cardiovascular
173d
Cleared
Nov 21, 2019
Asahi PTCA Guide Wire Asahi SION Series
Asahi Intecc Co., Ltd.
Cardiovascular
171d
Cleared
Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
Scientia Vascular, LLC
Neurology
30d
Cleared
Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
Phenox Limited
Neurology
107d
Cleared
Aug 01, 2019
MINAMO
Asahi Intecc Co., Ltd.
Cardiovascular
181d
Cleared
Jul 22, 2019
Roadrunner PC Wire Guide, Olcott Torque Device
Cook Incorporated
Cardiovascular
266d
Cleared
Jul 01, 2019
ASAHI Silverway
Asahi Intecc Co., Ltd.
Cardiovascular
238d
Cleared
Apr 18, 2019
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
Brivant Limited (Lake Region Medical)
Cardiovascular
223d
Cleared
Mar 11, 2019
Inno-Pathwire
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular
175d
Cleared
Feb 15, 2019
Lunderquist® Fixed Core Wire Guide
Cook Incorporated
Cardiovascular
269d
Cleared
Jan 11, 2019
Roadrunner Extra Support Wire Guide
Cook Incorporated
Cardiovascular
28d
Cleared
Dec 20, 2018
Reuter Tip Deflecting Wire Guide
Cook Incorporated
Cardiovascular
265d
Cleared
Sep 26, 2018
Magic Torque DLVR Guidewire
Boston Scientific Corporation
Cardiovascular
30d
Cleared
Jul 20, 2018
Bandit guidewire
Vascular Solutions, Inc.
Cardiovascular
28d
Cleared
Jul 18, 2018
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
Asahi Intecc Co., Ltd.
Cardiovascular
114d
Cleared
Jul 05, 2018
ASAHI PTCA Guide Wire ASAHI SION black
Asahi Intecc Co., Ltd.
Cardiovascular
265d
Cleared
Jun 18, 2018
Savion DLVR Guidewire, Savion FLX Guidewire
Boston Scientific, Inc.
Cardiovascular
90d
Cleared
Jun 14, 2018
Double Flexible Tipped Wire Guides
Cook Incorporated
Cardiovascular
23d
Cleared
May 03, 2018
Medtronic Confida Brecker Guidewire
Medtronic Core Valve, LLC
Cardiovascular
17d
Cleared
Apr 12, 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
Boston Scientific
Cardiovascular
16d
Cleared
Apr 11, 2018
Inno-Hydrowire
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular
265d