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
121–144 of 766
Cleared Feb 25, 2016
ASAHI Astato XS 40
K153443
Asahi Intecc Co., Ltd.
Cardiovascular · 90d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Nov 18, 2015
R350 guidewire
K151234
Vascular Solutions, Inc.
Cardiovascular · 194d
Cleared Jun 30, 2015
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV)
K150445
Asahi Intecc Co., Ltd.
Cardiovascular · 130d
Cleared May 28, 2015
Heavy Double Flexible Tipped Wire Guide
K150802
Cook Incorporated
Cardiovascular · 63d
Cleared Mar 11, 2015
Attain Hybrid Guide Wire
K143316
Medtronic, Inc.
Cardiovascular · 112d
Cleared Jan 15, 2015
ChoICE Guide Wire, Mailman Guide Wire, Luge Guide Wire, ChoICE PT Guide Wire, PT Graphix Wire
K143587
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Dec 17, 2014
PRELUDE PLASTIC JACKETED GUIDE WIRE
K142051
Merit Medical Systems, Inc.
Cardiovascular · 142d
Cleared Dec 16, 2014
MERIT HYDROPHILIC GUIDEWIRE
K141295
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
K142254
St Jude Medical
Cardiovascular · 91d
Cleared Oct 23, 2014
ASAHI RG3 GUIDEWIRE/ASAHI RG3 SOFT GUIDEWIRE
K141339
Asahi Intecc Co., Ltd.
Cardiovascular · 155d
Cleared Sep 12, 2014
MERIT HEPARIN-COATED INQWIRE DIAGNOSTIC GUIDEWIRE
K140608
Merit Medical Systems, Inc.
Cardiovascular · 186d
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
K140695
Medtronic, Inc.
Cardiovascular · 85d
Cleared Apr 16, 2014
INSERTION TOOL
K140673
Boston Scientific Corp
Cardiovascular · 29d
Cleared Mar 18, 2014
ASAHI GAIA FIRST, SECOND, THIRD
K133865
Asahi Intecc Co., Ltd.
Cardiovascular · 89d
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 Jul 29, 2013
MERIT HYDROPHILIC GUIDE WIRE
K131710
Merit Medical Systems, Inc.
Cardiovascular · 48d
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