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 16, 2014
INSERTION TOOL
K140673
Boston Scientific Corp
Cardiovascular · 29d
Cleared Apr 07, 2014
HYDROPHILIC COATED GUIDEWIRE
K133155
Lake Region Medical
Cardiovascular · 172d
Cleared Mar 27, 2014
MANDREL GUIDEWIRE
K140485
Lake Region Medical
Cardiovascular · 29d
Cleared Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865
Asahi Intecc Co., Ltd.
Cardiovascular · 89d
Cleared Feb 06, 2014
VDRIVE WITH V-SONO
K133396
Stereotaxis, Inc.
Cardiovascular · 92d
Cleared Dec 19, 2013
MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE
K132623
Medtronic
Cardiovascular · 119d
Cleared Dec 12, 2013
INQWIRE DIAGNOSTIC GUIDE WIRE
K133230
Merit Medical Systems, Inc.
Cardiovascular · 52d
Cleared Nov 08, 2013
MEDIVALVE ACWIRE
K132545
Medivalve , Ltd.
Cardiovascular · 87d
Cleared Aug 30, 2013
HORIZON XVU (FFR)
K123792
Mennen Medical , Ltd.
Cardiovascular · 263d
Cleared Aug 23, 2013
PRE-FORMED GUIDEWIRES
K130798
Lake Region Medical, Inc.
Cardiovascular · 154d
Cleared Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710
Merit Medical Systems, Inc.
Cardiovascular · 48d
Cleared Jul 26, 2013
VDRIVE W/V-SONO
K122659
Stereotaxis, Inc.
Cardiovascular · 329d
Cleared Jul 17, 2013
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K130766
Cook, Inc.
Cardiovascular · 119d
Cleared Jun 21, 2013
VERRATA PRESSURE GUIDE WIRE
K131288
Volcano Corporation
Cardiovascular · 46d
Cleared Jun 13, 2013
GUIDEWIRE, PURSUER SERIES
K130104
Oscor, Inc.
Cardiovascular · 149d
Cleared Apr 05, 2013
MERIT HYDROPHILIC GUIDE WIRE
K130588
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
K122468
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
K122469
Asahi Intecc Co., Ltd.
Cardiovascular · 207d
Cleared Mar 07, 2013
SILVERSPEED HYDROPHILIC GUIDEWIRE, X-CELERATOR HYDROPHILIC EXCHANGE GUIDEWIRE, X-PEDION HYDROPHILIC GUIDEWIRE, MIRAGE HY
K124007
Micro Therapeutics, Inc. D/B/A: Ev3, Inc.
Cardiovascular · 71d
Cleared Mar 01, 2013
RADIFOCUS GLIDEWIRE ADVANTAGE, RADIFOCUS GLIDEWIRE ADVANTAGE
K122590
Terumo Medical Corporation
Cardiovascular · 189d
Cleared Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707
Cook, Inc.
Cardiovascular · 87d
Cleared Jan 29, 2013
PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY
K123067
Abbott Vascular, Inc.
Cardiovascular · 120d
Cleared Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Dec 13, 2012
CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF)
K121398
Guidepath Medical, Inc.
Cardiovascular · 218d