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 Nov 20, 2012
HI-TORQUE COMMAND GUIDE WIRE FAMILY
K122573
Abbott Vascular, Inc.
Cardiovascular · 89d
Cleared Nov 08, 2012
STINGRAY GUIDEWIRES
K122795
Bridgepoint Medical
Cardiovascular · 57d
Cleared Oct 26, 2012
TORQUE DEVICE
K123024
Boston Scientific Corporation
Cardiovascular · 28d
Cleared Oct 17, 2012
CHARTER GUIDEWIRE
K122856
Brivant, Ltd.
Cardiovascular · 29d
Cleared Sep 21, 2012
OSTIAL PRO STENT POSITIONING SYSTEM
K122089
Merit Medical Systems, Inc.
Cardiovascular · 67d
Cleared Sep 19, 2012
MERIT HYDROPHILIC GUIDE WIRE
K120644
Merit Medical Systems, Inc.
Cardiovascular · 201d
Cleared Sep 17, 2012
SUREFIRE HIGH FLOW ANGIOGRAPHIC CATHETER, ACCESS
K122506
Surefire Medical, Inc.
Cardiovascular · 31d
Cleared Aug 14, 2012
AGILITY STEERABLE GUIDEWIRE NEUROSCOUT STEERABLE GUDIEWIRE
K121776
Codman & Shurtleff, Inc.
Cardiovascular · 57d
Cleared Jul 20, 2012
SLIDEWIRETM(TRADEMARK PENDING)
K113162
Acme-Monaco Corp.
Cardiovascular · 268d
Cleared Jul 20, 2012
DISPOSABLE TORQUE DEVICE
K113498
Coeur, Inc.
Cardiovascular · 238d
Cleared Jul 13, 2012
MANTARAY GUIDEWIRES
K121745
Bridgepoint Medical
Cardiovascular · 29d
Cleared Jul 06, 2012
NAVIS TORQUER
K112674
Navis Medical,Inc
Cardiovascular · 296d
Cleared May 11, 2012
SUNMED GUIDE WIRE
K120119
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 115d
Cleared May 08, 2012
CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
K120298
St. Jude Medical, Cardiac Rhythm Management Divisi
Cardiovascular · 98d
Cleared Apr 19, 2012
WHOLEY GUIDE WIRE SYSTEM
K120863
Covidien, LLC
Cardiovascular · 28d
Cleared Apr 18, 2012
MANTARAY GUIDEWIRES
K120881
Bridgepoint Medical
Cardiovascular · 26d
Cleared Feb 24, 2012
14 WIRE STANDARD, 14 WIRE LS
K113454
Micro Therapeutics, Inc.
Cardiovascular · 95d
Cleared Feb 14, 2012
VICTORY GUIDEWIRE (32 MODELS)
K120137
Brivant, Ltd.
Cardiovascular · 28d
Cleared Feb 06, 2012
ASAHI CHIKAI V PERIPHERAL VASCULAR GUIDE WIRE
K113716
Asahi Intecc Co., Ltd.
Cardiovascular · 49d
Cleared Nov 08, 2011
HI-TORQUE POWERTURN
K112957
Abbott Vascular-Cardiac Therapies
Cardiovascular · 35d
Cleared Nov 03, 2011
HI TORQUE CONNECT GUIDEWIRE
K112381
Lake Region Medical
Cardiovascular · 78d
Cleared Oct 27, 2011
VSI GUIDEWIRE
K112631
Vascular Solutions, Inc.
Cardiovascular · 48d
Cleared Oct 18, 2011
V-14 CONTROL WIRE GUIDEWIRE
K112745
Boston Scientific Corporation
Cardiovascular · 27d
Cleared Sep 09, 2011
ASAHI ULTIMATEBROS 3 PTCA GUIDE WIRE
K101986
Asahi Intecc Co., Ltd.
Cardiovascular · 422d