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
337–360 of 766
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 Nov 27, 2002
ENDOVASCULAR GUIDE WIRE
K021363
Stereotaxis, Inc.
Cardiovascular · 211d
Cleared Oct 28, 2002
HI-TORQUE WHISPER LS
K023300
Guidant Corp.
Cardiovascular · 25d
Cleared Oct 16, 2002
TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815
K022357
Boston Scientific, Target
Cardiovascular · 89d
Cleared Jul 26, 2002
ILT ADVANCING MECHANISM, MODEL A115AMI
K021638
Intra Luminal Therapeutics, Inc.
Cardiovascular · 67d
Cleared Jul 11, 2002
ILT TORQUER, MODEL 114TR1
K021243
Intra Luminal Therapeutics, Inc.
Cardiovascular · 83d
Cleared Jun 03, 2002
SCOUT (SINUS CORNARIUS UTILITY TOOL), MODEL 335 117
K020821
Biotronik, Inc.
Cardiovascular · 82d
Cleared May 22, 2002
MODIFICATION TO SAFE-STEER GUIDE WIRE SYSTEM
K021323
Intra Luminal Therapeutics, Inc.
Cardiovascular · 26d
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 Apr 03, 2002
SAFE-STEER GUIDE WIRE SYSTEM
K011986
Intra Luminal Therapeutics, Inc.
Cardiovascular · 281d
Cleared Mar 07, 2002
BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
K014075
Baylis Medical Co., Inc.
Cardiovascular · 86d
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 Feb 05, 2002
VASCUPUNCTURE ACCESS WIRE
K012861
Neometrics, Inc.
Cardiovascular · 165d
Cleared Jan 24, 2002
HI-TORQUE MIDDLE SUPPORT .012 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K012534
Advanced Cardiovascular Systems, Inc.
Cardiovascular · 171d
Cleared Jan 16, 2002
HI-TOQUE BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, #1009659,1009659J, 1009660, 10096
K013833
Guidant Corp.
Cardiovascular · 58d
Cleared Dec 13, 2001
HI-TOQUE WHISPER LS AND MS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
K013092
Guidant Corp.
Cardiovascular · 87d
Cleared Dec 04, 2001
SELECTIVA GUIDEWIRE
K013024
Neometrics, Inc.
Cardiovascular · 88d
Cleared Aug 28, 2001
SNIPER ELITE MODEL-OR-E3872XX SERIES
K011905
Maxxim Medical
Cardiovascular · 70d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906
Boston Scientific Corp
Cardiovascular · 55d