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
217–240 of 766
Cleared Aug 03, 2004
ASAHI PTCA GUIDE WIRE CONFIANZA PRO
K041531
Asahi Intecc Co., Ltd.
Cardiovascular · 56d
Cleared Jul 16, 2004
PTCA STEERABLE HYDROPHILIC GUIDEWIRE
K041624
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared May 17, 2004
LAKE REGION HYDROPHILIC GUIDEWIRE
K040825
Lake Region Mfg., Inc.
Cardiovascular · 48d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867
Boston Scientific Corp
Cardiovascular · 28d
Cleared Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
K040345
Ev3, Inc.
Cardiovascular · 19d
Cleared Mar 01, 2004
ARROW ECHOGENIC INTRODUCER NEEDLE
K040100
Arrow Intl., Inc.
Cardiovascular · 41d
Cleared Feb 12, 2004
IQ GUIDE WIRE
K040140
Boston Scientific Corp
Cardiovascular · 21d
Cleared Jan 12, 2004
BOSTON SCIENTIFIC V-18 CONTROL WIRE
K033742
Boston Scientific Corp
Cardiovascular · 45d
Cleared Dec 19, 2003
HYDROPHILIC GUIDEWIRE
K033758
Lake Region Mfg., Inc.
Cardiovascular · 17d
Cleared Sep 16, 2003
ASAHI PTCA CATHETER GUIDE WIRES, MODELS AGH147000 AND AGH147300
K032615
Asahi Intecc Co., Ltd.
Cardiovascular · 22d
Cleared Aug 26, 2003
HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K031678
Guidant Corp.
Cardiovascular · 88d
Cleared Aug 13, 2003
PBN GUIDEWIRES
K031442
Medical Device Technologies, Inc.
Cardiovascular · 99d
Cleared Aug 08, 2003
PERIVAC KIT
K032050
Boston Scientific Corp
Cardiovascular · 37d
Cleared Aug 01, 2003
IQ HYDROPHILIC GUIDE WIRE
K032183
Boston Scientific Corp
Cardiovascular · 15d
Cleared May 21, 2003
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
K030617
Boston Scientific Scimed, Inc.
Cardiovascular · 84d
Cleared Feb 14, 2003
STEERABLE GUIDEWIRE
K022813
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Jan 24, 2003
MODIFICATION TO HI-TORQUE WHISPER GUIDEWIRE
K030019
Guidant Corp.
Cardiovascular · 21d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300
Guidant Corp.
Cardiovascular · 25d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821
Biotronik, Inc.
Cardiovascular · 82d
Cleared May 15, 2002
HI-TORQUE BALANCE, BALANCE MIDDLEWEIGHT, BALANCE HEAVYWEIGHT, BALANCE TREK AND THE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE
K021228
Guidant Corp.
Cardiovascular · 27d
Cleared May 02, 2002
HI-TORQUE EXTRA S'PORT GUIDEWIRE
K021285
Guidant Corp.
Cardiovascular · 14d
Cleared Mar 01, 2002
MODIFICATION TO HI-TORQUE WHISPER LS AND MS GUIDE WIRES WITH HYDROCOAT HYDROPHILIC COATING
K020340
Guidant Corp.
Cardiovascular · 28d
Cleared Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283
Boston Scientific Corp
Cardiovascular · 14d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d