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
Aug 02, 2011
ANCHORWIRE GUIDEWIRE
Lake Region Medical
Cardiovascular
88d
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
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
Bridgepoint Medical
Cardiovascular
30d
Cleared
Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
Boston Scientific Corp
Cardiovascular
30d
Cleared
May 18, 2011
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
Brivant, Ltd.
Cardiovascular
182d
Cleared
Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
Boston Scientific Corp
Cardiovascular
49d
Cleared
Mar 18, 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
Asahi Intecc USA, Inc.
Cardiovascular
18d
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 25, 2011
ENDOLOGIX GUIDEWIRE
Techdevice Corporation
Cardiovascular
29d
Cleared
Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
Cook, Inc.
Cardiovascular
30d
Cleared
Dec 03, 2010
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
Micrus Endovascular Corporation
Cardiovascular
66d
Cleared
Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
35d
Cleared
Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
Neometrics, Inc.
Cardiovascular
94d
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
Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
Abbott Vascular, Inc.
Cardiovascular
27d
Cleared
Jun 17, 2010
HASKAL TORQUE DEVICE
Elcam Medical Acal
Cardiovascular
121d
Cleared
May 24, 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
Abbott Vascular, Inc.
Cardiovascular
42d
Cleared
Apr 30, 2010
VSI TORQUE DEVICE
Vascular Solutions, Inc.
Cardiovascular
107d
Cleared
Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
Volcano Corporation
Cardiovascular
25d
Cleared
Apr 28, 2010
ROLL-X GUIDEWIRE
St Jude Medical
Cardiovascular
47d
Cleared
Apr 21, 2010
GTX 12 GIDEWIRE
Medtronic, Inc.
Cardiovascular
62d