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
145–168 of 766
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 Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
K123707
Cook, Inc.
Cardiovascular · 87d
Cleared Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
K123609
Merit Medical Systems, Inc.
Cardiovascular · 56d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644
Merit Medical Systems, Inc.
Cardiovascular · 201d
Cleared Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776
Codman & Shurtleff, Inc.
Cardiovascular · 57d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863
Covidien, LLC
Cardiovascular · 28d
Cleared Feb 24, 2012
14 WIRE STANDARD, 14 WIRE LS
K113454
Micro Therapeutics, Inc.
Cardiovascular · 95d
Cleared Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716
Asahi Intecc Co., Ltd.
Cardiovascular · 49d
Cleared Oct 27, 2011
VSI GUIDEWIRE
K112631
Vascular Solutions, Inc.
Cardiovascular · 48d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
K101986
Asahi Intecc Co., Ltd.
Cardiovascular · 422d
Cleared Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
K111395
Volcano Corporation
Cardiovascular · 74d
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498
Boston Scientific Corp
Cardiovascular · 30d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479
Boston Scientific Corp
Cardiovascular · 49d
Cleared Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985
Asahi Intecc Co., Ltd.
Cardiovascular · 236d
Cleared Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
K110163
Cook Incorporated
Cardiovascular · 37d
Cleared Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009
Cook, Inc.
Cardiovascular · 30d
Cleared Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057
Asahi Intecc Co., Ltd.
Cardiovascular · 35d
Cleared Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
K100578
Asahi Intecc Co., Ltd.
Cardiovascular · 205d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339
Medtronic, Inc.
Cardiovascular · 111d
Cleared Apr 30, 2010
VSI TORQUE DEVICE
K100093
Vascular Solutions, Inc.
Cardiovascular · 107d