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
289–312 of 766
Cleared Mar 24, 2006
TITAN GUIDEWIRE
K060454
Lake Region Mfg., Inc.
Cardiovascular · 30d
Cleared Mar 13, 2006
PVS 2000 SYNCHRO2 GUIDEWIRE
K053268
Boston Scientific - Precision Vascular
Cardiovascular · 110d
Cleared Mar 08, 2006
TECHDEVICE GUIDEWIRE
K053251
Techdevice Corporation
Cardiovascular · 107d
Cleared Feb 17, 2006
TITAN STEERABLE (PTCA) GUIDEWIRE
K052347
Lake Region Mfg., Inc.
Cardiovascular · 172d
Cleared Nov 30, 2005
ASAHI PTCA GUIDE WIRE
K052339
Asahi Intecc Co., Ltd.
Cardiovascular · 96d
Cleared Oct 27, 2005
MODIFICATION TO: IQ GUIDE WIRE, MODELS 38950-XX. 38951-XX
K052783
Boston Scientific Corp
Cardiovascular · 24d
Cleared Aug 25, 2005
ASAHI PTCA GUIDE WIRE FIELDER
K052022
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Jul 15, 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
K051062
Flowcardia, Inc.
Cardiovascular · 80d
Cleared Jun 23, 2005
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM
K051374
Stereotaxis, Inc.
Cardiovascular · 28d
Cleared Jun 13, 2005
PV 1900 SYNCHRO 0.016 GUIDEWIRE
K050964
Boston Scientific - Precision Vascular
Cardiovascular · 56d
Cleared Jun 07, 2005
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY]
K050915
Intra Luminal Therapeutics, Inc.
Cardiovascular · 56d
Cleared May 26, 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873
Medical Device Technologies, Inc.
Cardiovascular · 50d
Cleared May 05, 2005
SKIPPER AND SKIPPER RACE GUIDEWIRE
K050756
Invatec Innovative Technologies, S.R.L.
Cardiovascular · 43d
Cleared Mar 02, 2005
GALEO FOCUS GUIDE WIRE
K042373
Biotronik, Inc.
Cardiovascular · 182d
Cleared Mar 01, 2005
MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE
K043398
Neometrics, Inc.
Cardiovascular · 81d
Cleared Feb 28, 2005
MODIFICATION TO ENDOVASCULAR GUIDE WIRE
K043457
Stereotaxis, Inc.
Cardiovascular · 75d
Cleared Feb 08, 2005
STEREOTAXIS ENDOVASCULAR GUIDE WIRE
K042854
Stereotaxis, Inc.
Cardiovascular · 116d
Cleared Jan 12, 2005
ASAHI PTCA GUIDE WIRE, J SHAPE SERIES
K043422
Asahi Intecc Co., Ltd.
Cardiovascular · 30d
Cleared Dec 17, 2004
CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE
K040592
Cordis Corp.
Cardiovascular · 284d
Cleared Dec 17, 2004
TORAYGUIDE GUIDEWIRE
K042370
Toray Industries (America), Inc.
Cardiovascular · 108d
Cleared Nov 24, 2004
GUIDEWIRES
K042264
Rocket Medical Plc
Cardiovascular · 93d
Cleared Nov 24, 2004
COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE
K042996
Volcano Therapeutics, Inc.
Cardiovascular · 23d
Cleared Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611
Cook, Inc.
Cardiovascular · 49d
Cleared Oct 15, 2004
SILICONE COATED GUIDEWIRE
K041740
Arrow International, Inc.
Cardiovascular · 109d