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 Cordis Corp., Boston Scientific Corp and Asahi Intecc Co., Ltd..

764
Total
764
Cleared
116d
Avg days
1976
Since
764 devices
121–144 of 764
Cleared Jun 12, 2014
COUGAR GUIDEWIRE, ZINGER GUIDWIRE, THUNDER GUIDEWIRE, PROVIA GUIDEWIRE, INTUITION GUIDEWIRE
K140695
Medtronic, Inc.
Cardiovascular · 85d
Cleared Apr 16, 2014
INSERTION TOOL
K140673
Boston Scientific Corp
Cardiovascular · 29d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498
Boston Scientific Corp
Cardiovascular · 30d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479
Boston Scientific Corp
Cardiovascular · 49d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339
Medtronic, Inc.
Cardiovascular · 111d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470
Medtronic, Inc.
Cardiovascular · 62d
Cleared Dec 04, 2009
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
K091582
Medtronic Vascular
Cardiovascular · 185d
Cleared Jul 02, 2009
ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE
K090554
Boston Scientific Corp
Cardiovascular · 122d
Cleared Feb 06, 2009
MEDTRONIC ANGIOGRAPHIC GUIDE WIRES
K082873
Medtronic Vascular
Cardiovascular · 130d
Cleared Aug 08, 2008
KINETIX GUIDEWIRE, PLUS GUIDEWIRE
K081021
Boston Scientific Corp
Cardiovascular · 120d
Cleared Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783
Boston Scientific Corp
Cardiovascular · 24d
Cleared Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592
Cordis Corp.
Cardiovascular · 284d
Cleared Apr 30, 2004
PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
K040867
Boston Scientific Corp
Cardiovascular · 28d
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 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 Feb 11, 2002
BACK-UP MEIER STEERABLE GUIDEWIRE
K020283
Boston Scientific Corp
Cardiovascular · 14d
Cleared Aug 13, 2001
BACK-UP MEIER GUIDEWIRE
K011906
Boston Scientific Corp
Cardiovascular · 55d
Cleared Jan 13, 2000
ATW MARKER WIRE STEERABLE GUIDEWIRE
K994358
Cordis Corp.
Cardiovascular · 17d
Cleared Nov 02, 1999
BARD HYDROPHILIC COATED GUIDE WIRES
K993000
C.R. Bard, Inc.
Cardiovascular · 56d