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
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
Sep 25, 2009
HI-TORQUE PROGRESS GUIDE WIRE FAMILY
Abbott Vascular, Inc.
Cardiovascular
98d
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
Mar 11, 2009
HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05
Abbott Vascular
Cardiovascular
85d
Cleared
Mar 03, 2009
MICRUS ONE 2 ONE GUIDEWIRE AND SOFT GUIDEWIRE
Micrus Endovascular Corporation
Cardiovascular
27d
Cleared
Feb 25, 2009
TAD AND TAD II TAPERED GUIDE WIRES
Abbott Vascular
Cardiovascular
71d
Cleared
Feb 23, 2009
.035 LOC GUIDE WIRE EXTENSION
Abbott Vascular
Cardiovascular
70d
Cleared
Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
Medtronic Vascular
Cardiovascular
130d
Cleared
Feb 06, 2009
HI-TORQUE VERSACORE GUIDE WIRE
Abbott Vascular
Cardiovascular
53d
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 12, 2008
POWERASSET RADIOFREQUENCY GUIDWIRE, MODEL VARIOUS
Stereotaxis, Inc.
Cardiovascular
159d
Cleared
Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
Boston Scientific Corp
Cardiovascular
120d