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
Mar 24, 2006
TITAN GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
30d
Cleared
Mar 13, 2006
PVS 2000 SYNCHRO2 GUIDEWIRE
Boston Scientific - Precision Vascular
Cardiovascular
110d
Cleared
Mar 08, 2006
TECHDEVICE GUIDEWIRE
Techdevice Corporation
Cardiovascular
107d
Cleared
Feb 17, 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
Lake Region Mfg., Inc.
Cardiovascular
172d
Cleared
Nov 30, 2005
ASAHI PTCA GUIDE WIRE
Asahi Intecc Co., Ltd.
Cardiovascular
96d
Cleared
Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
Boston Scientific Corp
Cardiovascular
24d
Cleared
Aug 25, 2005
ASAHI PTCA GUIDE WIRE FIELDER
Asahi Intecc Co., Ltd.
Cardiovascular
30d
Cleared
Jul 15, 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
Flowcardia, Inc.
Cardiovascular
80d
Cleared
Jun 23, 2005
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
Stereotaxis, Inc.
Cardiovascular
28d
Cleared
Jun 13, 2005
PV 1900 SYNCHRO 0.016 GUIDEWIRE
Boston Scientific - Precision Vascular
Cardiovascular
56d
Cleared
Jun 07, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
Intra Luminal Therapeutics, Inc.
Cardiovascular
56d
Cleared
May 26, 2005
CANALIZER HYDROPHILIC GUIDE WIRE
Medical Device Technologies, Inc.
Cardiovascular
50d
Cleared
May 05, 2005
SKIPPER AND SKIPPER RACE GUIDEWIRE
Invatec Innovative Technologies, S.R.L.
Cardiovascular
43d
Cleared
Mar 02, 2005
GALEO FOCUS GUIDE WIRE
Biotronik, Inc.
Cardiovascular
182d
Cleared
Mar 01, 2005
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
Neometrics, Inc.
Cardiovascular
81d
Cleared
Feb 28, 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
Stereotaxis, Inc.
Cardiovascular
75d
Cleared
Feb 08, 2005
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
Stereotaxis, Inc.
Cardiovascular
116d
Cleared
Jan 12, 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
Asahi Intecc Co., Ltd.
Cardiovascular
30d
Cleared
Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
Cordis Corp.
Cardiovascular
284d
Cleared
Dec 17, 2004
TORAYGUIDE GUIDEWIRE
Toray Industries (America), Inc.
Cardiovascular
108d
Cleared
Nov 24, 2004
GUIDEWIRES
Rocket Medical Plc
Cardiovascular
93d
Cleared
Nov 24, 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
Volcano Therapeutics, Inc.
Cardiovascular
23d
Cleared
Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
Cook, Inc.
Cardiovascular
49d
Cleared
Oct 15, 2004
SILICONE COATED GUIDEWIRE
Arrow International, Inc.
Cardiovascular
109d