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
Sep 21, 2015
Hi-Torque Command 18 Guide Wire
Abbott Vascular
Cardiovascular
27d
Cleared
Aug 03, 2015
Medtronic Confida Brecker Guidewire
Medtronic Core Valve, LLC
Cardiovascular
161d
Cleared
Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
Asahi Intecc Co., Ltd.
Cardiovascular
130d
Cleared
Jun 12, 2015
Opto Wire and OptoMonitor System
Opsens, Inc.
Cardiovascular
270d
Cleared
Jun 11, 2015
Pre-Formed Guidewire
Lake Region Medical
Cardiovascular
31d
Cleared
May 28, 2015
Heavy Double Flexible Tipped Wire Guide
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)
Needle Tech Products, Inc.
Cardiovascular
161d
Cleared
Mar 11, 2015
Attain Hybrid Guide Wire
Medtronic, Inc.
Cardiovascular
112d
Cleared
Feb 20, 2015
Spring Coil Guidewire
Neometrics, Inc.
Cardiovascular
112d
Cleared
Jan 21, 2015
ULTRASKIN HYDROPHILIC GUIDE WIRE
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
Boston Scientific Corporation
Cardiovascular
28d
Cleared
Dec 19, 2014
Hi-Torque JET Guide Wire Family
Abbott Vascular, Inc.
Cardiovascular
113d
Cleared
Dec 18, 2014
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM
Vadiswire Corporation
Cardiovascular
220d
Cleared
Dec 17, 2014
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE
Lake Region Medical
Cardiovascular
288d
Cleared
Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
142d
Cleared
Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
Merit Medical Systems, Inc.
Cardiovascular
211d
Cleared
Dec 10, 2014
DISTAL ACCESS TORQUE DEVICE
Distal Access, LLC
Cardiovascular
236d
Cleared
Nov 25, 2014
PREDICATE III GUIDEWIRE
Lake Region Medical
Cardiovascular
90d
Cleared
Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
St Jude Medical
Cardiovascular
91d
Cleared
Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
Asahi Intecc Co., Ltd.
Cardiovascular
155d
Cleared
Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
Merit Medical Systems, Inc.
Cardiovascular
186d
Cleared
Sep 04, 2014
HYDRAVIEW GUIDEWIRE
Brivant Limited
Cardiovascular
59d
Cleared
Aug 07, 2014
HI-TORQUE VERSATURN GUIDE WIRE
Abbott Vascular
Cardiovascular
36d
Cleared
Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
Medtronic, Inc.
Cardiovascular
85d