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