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 02, 2011
ANCHORWIRE GUIDEWIRE
K111288
Lake Region Medical
Cardiovascular · 88d
Cleared Aug 01, 2011
PRIMEWIRE PRESTIGE PLUS
K111395
Volcano Corporation
Cardiovascular · 74d
Cleared Jun 30, 2011
FATHOM 16 STEERABLE GUIDEWIRE MODEL M001509XXX
K111485
Boston Scientific Corporation
Cardiovascular · 30d
Cleared Jun 30, 2011
MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
K111488
Bridgepoint Medical
Cardiovascular · 30d
Cleared Jun 30, 2011
FATHOM (TM) 14 STEERABLE GUIDEWIRE
K111498
Boston Scientific Corp
Cardiovascular · 30d
Cleared May 18, 2011
CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283
K103377
Brivant, Ltd.
Cardiovascular · 182d
Cleared Apr 08, 2011
ACUITY WHISPER VIEW GUIDE WIRES
K110479
Boston Scientific Corp
Cardiovascular · 49d
Cleared Mar 18, 2011
ASAHI TREASURE FLOPPY PERIPHERAL GUIDE WIRE
K110553
Asahi Intecc USA, Inc.
Cardiovascular · 18d
Cleared Mar 07, 2011
ASAHI GUIDE WIRE EXTENSION 165CM
K101985
Asahi Intecc Co., Ltd.
Cardiovascular · 236d
Cleared Feb 25, 2011
APPROACH PRO ST WIRE GUIDE
K110163
Cook Incorporated
Cardiovascular · 37d
Cleared Feb 25, 2011
ENDOLOGIX GUIDEWIRE
K110241
Techdevice Corporation
Cardiovascular · 29d
Cleared Feb 02, 2011
ROADRUNNER UNIGLIDE HYDROPHILIC WIRE GUIDE
K110009
Cook, Inc.
Cardiovascular · 30d
Cleared Dec 03, 2010
MICRUS ONE 2 ONE GUIDEWIRE, MICRUS ONE 2 ONE SOFT GUIDEWIRE
K102818
Micrus Endovascular Corporation
Cardiovascular · 66d
Cleared Nov 19, 2010
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE
K103057
Asahi Intecc Co., Ltd.
Cardiovascular · 35d
Cleared Sep 23, 2010
NEOWIRE PTA/PTCA GUIDEWIRE
K101729
Neometrics, Inc.
Cardiovascular · 94d
Cleared Sep 22, 2010
ASAHI SION PTCA GUIDE WIRE MODEL AHW14R001S & AHW14R301S
K100578
Asahi Intecc Co., Ltd.
Cardiovascular · 205d
Cleared Aug 31, 2010
ARCHER SUPER STIFF GUIDEWIRES
K101339
Medtronic, Inc.
Cardiovascular · 111d
Cleared Jul 08, 2010
HI-TORQUE WINN GUIDE WIRE FAMILY
K101648
Abbott Vascular, Inc.
Cardiovascular · 27d
Cleared Jun 17, 2010
HASKAL TORQUE DEVICE
K100425
Elcam Medical Acal
Cardiovascular · 121d
Cleared May 24, 2010
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K101011
Abbott Vascular, Inc.
Cardiovascular · 42d
Cleared Apr 30, 2010
VSI TORQUE DEVICE
K100093
Vascular Solutions, Inc.
Cardiovascular · 107d
Cleared Apr 30, 2010
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J
K100930
Volcano Corporation
Cardiovascular · 25d
Cleared Apr 28, 2010
ROLL-X GUIDEWIRE
K100710
St Jude Medical
Cardiovascular · 47d
Cleared Apr 21, 2010
GTX 12 GIDEWIRE
K100470
Medtronic, Inc.
Cardiovascular · 62d