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
145–168 of 766
Cleared Sep 21, 2015
Hi-Torque Command 18 Guide Wire
K152404
Abbott Vascular
Cardiovascular · 27d
Cleared Aug 03, 2015
Medtronic Confida Brecker Guidewire
K150465
Medtronic Core Valve, LLC
Cardiovascular · 161d
Cleared Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445
Asahi Intecc Co., Ltd.
Cardiovascular · 130d
Cleared Jun 12, 2015
Opto Wire and OptoMonitor System
K142598
Opsens, Inc.
Cardiovascular · 270d
Cleared Jun 11, 2015
Pre-Formed Guidewire
K151244
Lake Region Medical
Cardiovascular · 31d
Cleared May 28, 2015
Heavy Double Flexible Tipped Wire Guide
K150802
Cook Incorporated
Cardiovascular · 63d
Cleared Apr 23, 2015
Galt Tork, 0.010 to 0.020 inches (yellow), Galt Tork, 0.025 to 0.040 inches (orange)
K143252
Needle Tech Products, Inc.
Cardiovascular · 161d
Cleared Mar 11, 2015
Attain Hybrid Guide Wire
K143316
Medtronic, Inc.
Cardiovascular · 112d
Cleared Feb 20, 2015
Spring Coil Guidewire
K143135
Neometrics, Inc.
Cardiovascular · 112d
Cleared Jan 21, 2015
ULTRASKIN HYDROPHILIC GUIDE WIRE
K141707
Lepu Medical Technology (Beijing) Co., Ltd.
Cardiovascular · 211d
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Dec 19, 2014
Hi-Torque JET Guide Wire Family
K142415
Abbott Vascular, Inc.
Cardiovascular · 113d
Cleared Dec 18, 2014
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
K141218
Vadiswire Corporation
Cardiovascular · 220d
Cleared Dec 17, 2014
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
K140536
Lake Region Medical
Cardiovascular · 288d
Cleared Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295
Merit Medical Systems, Inc.
Cardiovascular · 211d
Cleared Dec 10, 2014
DISTAL ACCESS TORQUE DEVICE
K141054
Distal Access, LLC
Cardiovascular · 236d
Cleared Nov 25, 2014
PREDICATE III GUIDEWIRE
K142393
Lake Region Medical
Cardiovascular · 90d
Cleared Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
K142254
St Jude Medical
Cardiovascular · 91d
Cleared Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339
Asahi Intecc Co., Ltd.
Cardiovascular · 155d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608
Merit Medical Systems, Inc.
Cardiovascular · 186d
Cleared Sep 04, 2014
HYDRAVIEW GUIDEWIRE
K141831
Brivant Limited
Cardiovascular · 59d
Cleared Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
K141782
Abbott Vascular
Cardiovascular · 36d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
K140695
Medtronic, Inc.
Cardiovascular · 85d