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
Feb 25, 2016
ASAHI Astato XS 40
Asahi Intecc Co., Ltd.
Cardiovascular
90d
Cleared
Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
Boston Scientific Corporation
Cardiovascular
189d
Cleared
Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Boston Scientific Corporation
Cardiovascular
163d
Cleared
Nov 18, 2015
R350 guidewire
Vascular Solutions, Inc.
Cardiovascular
194d
Cleared
Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
Asahi Intecc Co., Ltd.
Cardiovascular
130d
Cleared
May 28, 2015
Heavy Double Flexible Tipped Wire Guide
Cook Incorporated
Cardiovascular
63d
Cleared
Mar 11, 2015
Attain Hybrid Guide Wire
Medtronic, Inc.
Cardiovascular
112d
Cleared
Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
Boston Scientific Corporation
Cardiovascular
28d
Cleared
Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
142d
Cleared
Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
Merit Medical Systems, Inc.
Cardiovascular
211d
Cleared
Nov 13, 2014
CPS Excel MediGuide Enabled Guidewire, CPS Excel MediGuide Torque clip, CPS Excel MediGuide Guidewire Connector
St Jude Medical
Cardiovascular
91d
Cleared
Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
Asahi Intecc Co., Ltd.
Cardiovascular
155d
Cleared
Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
Merit Medical Systems, Inc.
Cardiovascular
186d
Cleared
Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
Medtronic, Inc.
Cardiovascular
85d
Cleared
Apr 16, 2014
INSERTION TOOL
Boston Scientific Corp
Cardiovascular
29d
Cleared
Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
Asahi Intecc Co., Ltd.
Cardiovascular
89d
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
Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
48d
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