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 16, 2014
INSERTION TOOL
Boston Scientific Corp
Cardiovascular
29d
Cleared
Apr 07, 2014
HYDROPHILIC COATED GUIDEWIRE
Lake Region Medical
Cardiovascular
172d
Cleared
Mar 27, 2014
MANDREL GUIDEWIRE
Lake Region Medical
Cardiovascular
29d
Cleared
Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
Asahi Intecc Co., Ltd.
Cardiovascular
89d
Cleared
Feb 06, 2014
VDRIVE WITH V-SONO
Stereotaxis, Inc.
Cardiovascular
92d
Cleared
Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
Medtronic
Cardiovascular
119d
Cleared
Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
52d
Cleared
Nov 08, 2013
MEDIVALVE ACWIRE
Medivalve , Ltd.
Cardiovascular
87d
Cleared
Aug 30, 2013
HORIZON XVU (FFR)
Mennen Medical , Ltd.
Cardiovascular
263d
Cleared
Aug 23, 2013
PRE-FORMED GUIDEWIRES
Lake Region Medical, Inc.
Cardiovascular
154d
Cleared
Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
48d
Cleared
Jul 26, 2013
VDRIVE W/V-SONO
Stereotaxis, Inc.
Cardiovascular
329d
Cleared
Jul 17, 2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Cook, Inc.
Cardiovascular
119d
Cleared
Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
Volcano Corporation
Cardiovascular
46d
Cleared
Jun 13, 2013
GUIDEWIRE, PURSUER SERIES
Oscor, Inc.
Cardiovascular
149d
Cleared
Apr 05, 2013
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
29d
Cleared
Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 180CM ASAHI PTCA GUIDE WIRE ASAHI SION BLUE 3300CM ASAHI PTCA GUIDE WIRE ASAHI SIO
Asahi Intecc Co., Ltd.
Cardiovascular
207d
Cleared
Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
Asahi Intecc Co., Ltd.
Cardiovascular
207d
Cleared
Mar 07, 2013
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
Cardiovascular
71d
Cleared
Mar 01, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
Terumo Medical Corporation
Cardiovascular
189d
Cleared
Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
Cook, Inc.
Cardiovascular
87d
Cleared
Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
Abbott Vascular, Inc.
Cardiovascular
120d
Cleared
Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
56d
Cleared
Dec 13, 2012
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
Guidepath Medical, Inc.
Cardiovascular
218d