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
73–96 of 764
Cleared Jan 02, 2020
ASAHI PTCA Guide Wire ASAHI Gaia Next
K192599
Asahi Intecc Co., Ltd.
Cardiovascular · 104d
Cleared Dec 13, 2019
CrossTorq 14 Guidewire
K193194
Scientia Cardio Access, LLC
Cardiovascular · 24d
Cleared Dec 11, 2019
HI-TORQUE InfilTrac Guide Wire Family
K193126
Abbott Vascular
Cardiovascular · 29d
Cleared Nov 26, 2019
Heraeus Peripheral Guidewire
K191502
Heraeus Medical Components, LLC
Cardiovascular · 173d
Cleared Nov 21, 2019
Asahi PTCA Guide Wire Asahi SION Series
K191464
Asahi Intecc Co., Ltd.
Cardiovascular · 171d
Cleared Oct 30, 2019
Aristotle 24 Guidewire, 200cm, Soft Profile
K192783
Scientia Vascular, LLC
Neurology · 30d
Cleared Oct 09, 2019
pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire
K191687
Phenox Limited
Neurology · 107d
Cleared Aug 01, 2019
MINAMO
K190176
Asahi Intecc Co., Ltd.
Cardiovascular · 181d
Cleared Jul 22, 2019
Roadrunner PC Wire Guide, Olcott Torque Device
K182985
Cook Incorporated
Cardiovascular · 266d
Cleared Jul 01, 2019
ASAHI Silverway
K183062
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
K182457
Brivant Limited (Lake Region Medical)
Cardiovascular · 223d
Cleared Mar 11, 2019
Inno-Pathwire
K182553
Suzhou Innomed Medical Device Co., Ltd.
Cardiovascular · 175d
Cleared Feb 15, 2019
Lunderquist® Fixed Core Wire Guide
K181353
Cook Incorporated
Cardiovascular · 269d
Cleared Jan 11, 2019
Roadrunner Extra Support Wire Guide
K183467
Cook Incorporated
Cardiovascular · 28d
Cleared Dec 20, 2018
Reuter Tip Deflecting Wire Guide
K180830
Cook Incorporated
Cardiovascular · 265d
Cleared Sep 26, 2018
Magic Torque DLVR Guidewire
K182315
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jul 20, 2018
Bandit guidewire
K181647
Vascular Solutions, Inc.
Cardiovascular · 28d
Cleared Jul 18, 2018
ASAHI PTCA Guide Wire ASAHI Gladius Mongo 14, ASAHI Gladius Mongo 14 ES
K180784
Asahi Intecc Co., Ltd.
Cardiovascular · 114d
Cleared Jul 05, 2018
ASAHI PTCA Guide Wire ASAHI SION black
K173277
Asahi Intecc Co., Ltd.
Cardiovascular · 265d
Cleared Jun 18, 2018
Savion DLVR Guidewire, Savion FLX Guidewire
K180726
Boston Scientific, Inc.
Cardiovascular · 90d
Cleared Jun 14, 2018
Double Flexible Tipped Wire Guides
K181351
Cook Incorporated
Cardiovascular · 23d
Cleared May 03, 2018
Medtronic Confida Brecker Guidewire
K181001
Medtronic Core Valve, LLC
Cardiovascular · 17d
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