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
265–288 of 766
Cleared Aug 08, 2008
APPROACH CTO WIRE GUIDE
K081337
Cook Incorporated
Cardiovascular · 87d
Cleared Apr 17, 2008
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE
K080863
MicroVention, Inc.
Cardiovascular · 20d
Cleared Apr 11, 2008
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE
K072460
Abbott Vascular, Inc.
Cardiovascular · 224d
Cleared Mar 20, 2008
RUNTHROUGH NS EXTENSION WIRE
K080563
Terumo Medical Corp.
Cardiovascular · 21d
Cleared Feb 26, 2008
MANDREL GUIDEWIRES OR M-WIRES
K080144
Lake Region Mfg., Inc.
Cardiovascular · 35d
Cleared Jan 28, 2008
PEGASUS STEERABLE (PTCA) GUIDEWIRE
K073655
Lake Region Mfg., Inc.
Cardiovascular · 33d
Cleared Jan 09, 2008
ASAHI PTCA GUIDE WIRE
K070945
Asahi Intecc Co., Ltd.
Cardiovascular · 280d
Cleared Dec 14, 2007
MERIT MEDICAL SYSTEMS, INC., GUIDE WIRE TORQUE DEVICE
K072552
Merit Medical Systems, Inc.
Cardiovascular · 95d
Cleared Oct 23, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC J, MODELS: AGP140001J, AGP140301J
K072705
Asahi Intecc Co., Ltd.
Cardiovascular · 29d
Cleared Sep 26, 2007
ASAHI PTCA GUIDE WIRE, X-TREME
K072431
Asahi Intecc Co., Ltd.
Cardiovascular · 28d
Cleared Aug 24, 2007
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K071029
Stereotaxis, Inc.
Cardiovascular · 135d
Cleared Jul 13, 2007
ASAHI ASTATO 30 PERIPHERAL GUIDE WIRE, MODELS - PAGH18M071, PAGH18M371
K071721
Asahi Intecc Co., Ltd.
Cardiovascular · 18d
Cleared Apr 27, 2007
RUNTHROUGH NS
K063695
Terumo Medical Corp.
Cardiovascular · 135d
Cleared Apr 27, 2007
COOK MICROWIRE WIRE GUIDE
K070410
Cook, Inc.
Cardiovascular · 74d
Cleared Feb 15, 2007
VASCUPUNCTURE PICC GUIDEWIRE
K070150
Neometrics, Inc.
Cardiovascular · 30d
Cleared Jan 26, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
Cleared Jan 19, 2007
LUNDERQUIST WIRE GUIDE
K061670
William Cook Europe Aps
Cardiovascular · 219d
Cleared Jan 19, 2007
RADIFOCUS GLIDEWIRE ADVANTAGE
K063372
Terumo Medical Corp.
Cardiovascular · 72d
Cleared Nov 09, 2006
ASAHI PTCA GUIDE WIRE, FIELDER J, MODEL AGP140000J, AGP140300J
K062186
Asahi Intecc Co., Ltd.
Cardiovascular · 101d
Cleared Oct 05, 2006
TREASURE
K061984
Asahi Intecc Co., Ltd.
Cardiovascular · 84d
Cleared Jun 22, 2006
HI-TORQUE WHISPER VIEW GUIDE WIRE
K061453
Guidant Corp.
Cardiovascular · 28d
Cleared May 30, 2006
HI-TORQUE ADVANCE AND ADVANCE LITE GUIDE WIRE
K060449
Guidant Corporation
Cardiovascular · 98d
Cleared Apr 28, 2006
MICRUS GUIDE WIRE, WATUSI 0.014
K053265
Micrus Endovascular Corporation
Cardiovascular · 157d
Cleared Apr 27, 2006
AMPLATZER NOODLEWIRE GUIDEWIRE
K053187
Aga Medical Corp.
Cardiovascular · 163d