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
169–192 of 766
Cleared Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930
Volcano Corporation
Cardiovascular · 25d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710
St Jude Medical
Cardiovascular · 47d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470
Medtronic, Inc.
Cardiovascular · 62d
Cleared Mar 16, 2010
NEUROSCOUT STEERABLE GUIDEWIRE
K100351
Codman & Shurtleff, Inc.
Cardiovascular · 32d
Cleared Feb 26, 2010
TRAILRUNNER GUIDEWIRES
K092965
Lake Region Mfg., Inc.
Cardiovascular · 154d
Cleared Feb 24, 2010
TRAXCESS DOCKING WIRE
K093647
MicroVention, Inc.
Cardiovascular · 91d
Cleared Dec 17, 2009
TRAXCESS 14EX GUIDEWIRE AND TRAXCESS DOCKING WIRE
K093397
MicroVention, Inc.
Cardiovascular · 48d
Cleared Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582
Medtronic Vascular
Cardiovascular · 185d
Cleared Oct 27, 2009
MERIT LAUREATE HYDROPHILIC GUIDE WIRE
K092303
Merit Medical Systems, Inc.
Cardiovascular · 90d
Cleared Aug 07, 2009
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW
K091385
Cook, Inc.
Cardiovascular · 89d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554
Boston Scientific Corp
Cardiovascular · 122d
Cleared Mar 25, 2009
THE MEDCOMP .010 VASCULAR GUIDEWIRES
K081775
Medcomp
Cardiovascular · 275d
Cleared Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873
Medtronic Vascular
Cardiovascular · 130d
Cleared Jan 29, 2009
ASAHI SUOH PTCA GUIDE WIRE
K083904
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 12, 2009
ASAHI GUIDE WIRE EXTENSION, MODEL AG149000
K083145
Asahi Intecc Co., Ltd.
Cardiovascular · 81d
Cleared Dec 09, 2008
FREEWAY AND RAILRUNNER GUIDEWIRES
K082922
Lake Region Mfg., Inc.
Cardiovascular · 69d
Cleared Dec 04, 2008
VISION WIRE CORONARY GUIDEWIRE
K082935
Biotronik, Inc.
Cardiovascular · 64d
Cleared Nov 21, 2008
ASAHI REGALIA XS 1.0 PERIPHERAL GUIDE WIRE, MODELS PAGP 140000 & PAGP 1403000
K083146
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Aug 27, 2008
ROLL-X GUIDEWIRE
K082304
St Jude Medical
Cardiovascular · 14d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021
Boston Scientific Corp
Cardiovascular · 120d
Cleared Aug 08, 2008
APPROACH CTO WIRE GUIDE
K081337
Cook Incorporated
Cardiovascular · 87d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863
MicroVention, Inc.
Cardiovascular · 20d
Cleared Mar 20, 2008
RUNTHROUGH NS EXTENSION WIRE
K080563
Terumo Medical Corp.
Cardiovascular · 21d
Cleared Feb 26, 2008
MANDREL GUIDEWIRES OR M-WIRES
K080144
Lake Region Mfg., Inc.
Cardiovascular · 35d