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 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
Volcano Corporation
Cardiovascular
25d
Cleared
Apr 28, 2010
ROLL-X GUIDEWIRE
St Jude Medical
Cardiovascular
47d
Cleared
Apr 21, 2010
GTX 12 GIDEWIRE
Medtronic, Inc.
Cardiovascular
62d
Cleared
Mar 16, 2010
NEUROSCOUT STEERABLE GUIDEWIRE
Codman & Shurtleff, Inc.
Cardiovascular
32d
Cleared
Feb 26, 2010
TRAILRUNNER GUIDEWIRES
Lake Region Mfg., Inc.
Cardiovascular
154d
Cleared
Feb 24, 2010
TRAXCESS DOCKING WIRE
MicroVention, Inc.
Cardiovascular
91d
Cleared
Dec 17, 2009
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
MicroVention, Inc.
Cardiovascular
48d
Cleared
Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
Medtronic Vascular
Cardiovascular
185d
Cleared
Oct 27, 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
90d
Cleared
Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
Cook, Inc.
Cardiovascular
89d
Cleared
Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
Boston Scientific Corp
Cardiovascular
122d
Cleared
Mar 25, 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
Medcomp
Cardiovascular
275d
Cleared
Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
Medtronic Vascular
Cardiovascular
130d
Cleared
Jan 29, 2009
ASAHI SUOH PTCA GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
31d
Cleared
Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
Asahi Intecc Co., Ltd.
Cardiovascular
81d
Cleared
Dec 09, 2008
FREEWAY AND RAILRUNNER GUIDEWIRES
Lake Region Mfg., Inc.
Cardiovascular
69d
Cleared
Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
Biotronik, Inc.
Cardiovascular
64d
Cleared
Nov 21, 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
Asahi Intecc Co., Ltd.
Cardiovascular
29d
Cleared
Aug 27, 2008
ROLL-X GUIDEWIRE
St Jude Medical
Cardiovascular
14d
Cleared
Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
Boston Scientific Corp
Cardiovascular
120d
Cleared
Aug 08, 2008
APPROACH CTO WIRE GUIDE
Cook Incorporated
Cardiovascular
87d
Cleared
Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
MicroVention, Inc.
Cardiovascular
20d
Cleared
Mar 20, 2008
RUNTHROUGH NS EXTENSION WIRE
Terumo Medical Corp.
Cardiovascular
21d
Cleared
Feb 26, 2008
MANDREL GUIDEWIRES OR M-WIRES
Lake Region Mfg., Inc.
Cardiovascular
35d