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 Asahi Intecc Co., Ltd., Advanced Cardiovascular Systems, Inc. and Lake Region Mfg., Inc..
766
Total
766
Cleared
116d
Avg days
1976
Since
766 devices
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
Cleared
Mar 30, 2018
Mandril Wire Guide
Cook Incorporated
Cardiovascular
270d
Cleared
Mar 19, 2018
Double Flexible Tip Wire Guides
Cook Incorporated
Cardiovascular
266d
Cleared
Mar 09, 2018
Fixed Core Wire Guides
Cook Incorporated
Cardiovascular
268d
Cleared
Feb 16, 2018
Warrior 14 guidewire
Vascular Solutions, Inc.
Cardiovascular
30d
Cleared
Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
Asahi Intecc Co., Ltd.
Cardiovascular
229d
Cleared
Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
Scientia Vascular, LLC
Cardiovascular
109d
Cleared
Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
Abbott Vascular
Cardiovascular
29d
Cleared
Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
Cook Incorporated
Cardiovascular
239d
Cleared
Jan 05, 2018
Roadrunner Extra Support Wire Guide
Cook Incorporated
Cardiovascular
190d
Cleared
Dec 15, 2017
Raider Guidewire
Vascular Solutions, Inc.
Cardiovascular
30d
Cleared
Dec 07, 2017
Lunderquist Extra Stiff Wire Guide
William Cook Europe Aps
Cardiovascular
197d
Cleared
Nov 21, 2017
TXM Hydrophilic Guidewire
Texasmedical Technologies, Inc.
Cardiovascular
238d
Cleared
Nov 17, 2017
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
Nano4imaging GmbH
Cardiovascular
16d
Cleared
Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
Boston Scientific Corporation
Cardiovascular
87d
Cleared
Oct 20, 2017
Heraeus TMW Guidewire
Heraeus Medical Components, LLC
Cardiovascular
22d
Cleared
Sep 15, 2017
Glidewire GT
Terumo Corporation
Cardiovascular
217d
Cleared
Aug 25, 2017
Hi-Torque Command 18 Guide Wire
Abbott Vascular
Cardiovascular
46d
Cleared
Aug 21, 2017
Approach CTO Microwire Guide
Cook Incorporated
Cardiovascular
56d
Cleared
Jul 21, 2017
True Form Reshapable Guide Wire
Merit Medical Systems, Inc.
Cardiovascular
149d
Cleared
Jun 29, 2017
Firebow Wire Torque Assist Device
Vesatek, LLC
Cardiovascular
114d
Cleared
Jun 22, 2017
Merit Hydrophilic Guide Wire
Merit Medical Systems, Inc.
Cardiovascular
85d
Cleared
Apr 06, 2017
Inqwire Diagnostic Guide Wire
Merit Medical Systems, Inc.
Cardiovascular
30d