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 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
Asahi Intecc Co., Ltd.
Cardiovascular
56d
Cleared
Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
30d
Cleared
May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
48d
Cleared
Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
Boston Scientific Corp
Cardiovascular
28d
Cleared
Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
Ev3, Inc.
Cardiovascular
19d
Cleared
Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
Arrow Intl., Inc.
Cardiovascular
41d
Cleared
Feb 12, 2004
IQ GUIDE WIRE
Boston Scientific Corp
Cardiovascular
21d
Cleared
Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
Boston Scientific Corp
Cardiovascular
45d
Cleared
Dec 19, 2003
HYDROPHILIC GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
17d
Cleared
Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
Asahi Intecc Co., Ltd.
Cardiovascular
22d
Cleared
Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Guidant Corp.
Cardiovascular
88d
Cleared
Aug 13, 2003
PBN GUIDEWIRES
Medical Device Technologies, Inc.
Cardiovascular
99d
Cleared
Aug 08, 2003
PERIVAC KIT
Boston Scientific Corp
Cardiovascular
37d
Cleared
Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
Boston Scientific Corp
Cardiovascular
15d
Cleared
May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
Boston Scientific Scimed, Inc.
Cardiovascular
84d
Cleared
Feb 14, 2003
STEERABLE GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
172d
Cleared
Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
Guidant Corp.
Cardiovascular
21d
Cleared
Oct 28, 2002
HI-TORQUE WHISPER LS
Guidant Corp.
Cardiovascular
25d
Cleared
Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
Biotronik, Inc.
Cardiovascular
82d
Cleared
May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
Guidant Corp.
Cardiovascular
27d
Cleared
May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
Guidant Corp.
Cardiovascular
14d
Cleared
Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
Guidant Corp.
Cardiovascular
28d
Cleared
Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
Boston Scientific Corp
Cardiovascular
14d
Cleared
Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
Advanced Cardiovascular Systems, Inc.
Cardiovascular
171d