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 Asahi Intecc Co., Ltd., Advanced Cardiovascular Systems, Inc. and Lake Region Mfg., Inc..

766
Total
766
Cleared
116d
Avg days
1976
Since
766 devices
97–120 of 766
Cleared Apr 12, 2018
JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
K180795
Boston Scientific
Cardiovascular · 16d
Cleared Apr 11, 2018
Inno-Hydrowire
K172187
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular · 265d
Cleared Mar 30, 2018
Mandril Wire Guide
K171997
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 19, 2018
Double Flexible Tip Wire Guides
K171912
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 09, 2018
Fixed Core Wire Guides
K171764
Cook Incorporated
Cardiovascular · 268d
Cleared Feb 16, 2018
Warrior 14 guidewire
K180128
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
K171933
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
K173235
Scientia Vascular, LLC
Cardiovascular · 109d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795
Abbott Vascular
Cardiovascular · 29d
Cleared Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
K171445
Cook Incorporated
Cardiovascular · 239d
Cleared Jan 05, 2018
Roadrunner Extra Support Wire Guide
K171948
Cook Incorporated
Cardiovascular · 190d
Cleared Dec 15, 2017
Raider Guidewire
K173532
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Dec 07, 2017
Lunderquist Extra Stiff Wire Guide
K171513
William Cook Europe Aps
Cardiovascular · 197d
Cleared Nov 21, 2017
TXM Hydrophilic Guidewire
K170915
Texasmedical Technologies, Inc.
Cardiovascular · 238d
Cleared Nov 17, 2017
MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
K173423
Nano4imaging GmbH
Cardiovascular · 16d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Oct 20, 2017
Heraeus TMW Guidewire
K173052
Heraeus Medical Components, LLC
Cardiovascular · 22d
Cleared Sep 15, 2017
Glidewire GT
K170417
Terumo Corporation
Cardiovascular · 217d
Cleared Aug 25, 2017
Hi-Torque Command 18 Guide Wire
K172073
Abbott Vascular
Cardiovascular · 46d
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897
Cook Incorporated
Cardiovascular · 56d
Cleared Jul 21, 2017
True Form Reshapable Guide Wire
K170532
Merit Medical Systems, Inc.
Cardiovascular · 149d
Cleared Jun 29, 2017
Firebow Wire Torque Assist Device
K170684
Vesatek, LLC
Cardiovascular · 114d
Cleared Jun 22, 2017
Merit Hydrophilic Guide Wire
K170933
Merit Medical Systems, Inc.
Cardiovascular · 85d
Cleared Apr 06, 2017
Inqwire Diagnostic Guide Wire
K170700
Merit Medical Systems, Inc.
Cardiovascular · 30d