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
Mar 08, 2013
ASAHI PTCA GUIDE WIRE ASAHI SION 180CMJ ASAHI PTCA GUIDE WIRE ASAHI SION 300CMJ
Asahi Intecc Co., Ltd.
Cardiovascular
207d
Cleared
Feb 28, 2013
ALIGHT 16 SUPERSELECTIVE MICROWIRE GUIDE
Cook, Inc.
Cardiovascular
87d
Cleared
Jan 16, 2013
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
56d
Cleared
Oct 26, 2012
TORQUE DEVICE
Boston Scientific Corporation
Cardiovascular
28d
Cleared
Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
Merit Medical Systems, Inc.
Cardiovascular
67d
Cleared
Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
Merit Medical Systems, Inc.
Cardiovascular
201d
Cleared
Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
Codman & Shurtleff, Inc.
Cardiovascular
57d
Cleared
Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
Covidien, LLC
Cardiovascular
28d
Cleared
Feb 24, 2012
14 WIRE STANDARD, 14 WIRE LS
Micro Therapeutics, Inc.
Cardiovascular
95d
Cleared
Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
49d
Cleared
Oct 27, 2011
VSI GUIDEWIRE
Vascular Solutions, Inc.
Cardiovascular
48d
Cleared
Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
Boston Scientific Corporation
Cardiovascular
27d
Cleared
Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
422d
Cleared
Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
Volcano Corporation
Cardiovascular
74d
Cleared
Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
Boston Scientific Corporation
Cardiovascular
30d
Cleared
Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
Boston Scientific Corp
Cardiovascular
30d
Cleared
Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
Boston Scientific Corp
Cardiovascular
49d
Cleared
Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
Asahi Intecc Co., Ltd.
Cardiovascular
236d
Cleared
Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
Cook Incorporated
Cardiovascular
37d
Cleared
Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Cook, Inc.
Cardiovascular
30d
Cleared
Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
35d
Cleared
Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
Asahi Intecc Co., Ltd.
Cardiovascular
205d
Cleared
Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
Medtronic, Inc.
Cardiovascular
111d
Cleared
Apr 30, 2010
VSI TORQUE DEVICE
Vascular Solutions, Inc.
Cardiovascular
107d