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
193–216 of 766
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 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 Jan 26, 2007
ASAHI PTCA GUIDE WIRE, FIELDER FC
K063819
Asahi Intecc Co., Ltd.
Cardiovascular · 31d
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 Mar 24, 2006
TITAN GUIDEWIRE
K060454
Lake Region Mfg., Inc.
Cardiovascular · 30d
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 May 26, 2005
CANALIZER HYDROPHILIC GUIDE WIRE
K050873
Medical Device Technologies, Inc.
Cardiovascular · 50d
Cleared Mar 02, 2005
GALEO FOCUS GUIDE WIRE
K042373
Biotronik, Inc.
Cardiovascular · 182d
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 Nov 12, 2004
LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE
K042611
Cook, Inc.
Cardiovascular · 49d
Cleared Sep 16, 2004
CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE
K042338
Lake Region Mfg., Inc.
Cardiovascular · 17d