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
121–144 of 766
Cleared Apr 03, 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
K163426
Asahi Intecc Co., Ltd.
Cardiovascular · 118d
Cleared Mar 22, 2017
Fathom-16 Steerable Guidewires
K170636
Boston Scientific Corporation
Cardiovascular · 20d
Cleared Mar 03, 2017
Inqwire Diagnostic Guide Wire
K163575
Merit Medical Systems, Inc.
Cardiovascular · 74d
Cleared Jan 30, 2017
Radifocus Glidewire Advantage Track
K163004
Ashitaka Factory of Terumo Coporation
Cardiovascular · 94d
Cleared Jan 27, 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
K162842
Asahi Intecc Co., Ltd.
Cardiovascular · 108d
Cleared Jan 06, 2017
Spectre guidewire
K163444
Vascular Solutions, Inc.
Cardiovascular · 29d
Cleared Dec 08, 2016
Worker Guidewire
K160785
Argon Medical Devices, Inc.
Cardiovascular · 261d
Cleared Dec 06, 2016
Endura guidewire
K161702
Vascular Solutions, Inc.
Cardiovascular · 169d
Cleared Nov 22, 2016
MRWire Guide Wire
K160594
Nano4imaging GmbH
Cardiovascular · 266d
Cleared Oct 18, 2016
ENROUTE 0.014 Guidewire
K160643
Lake Region Medical
Cardiovascular · 225d
Cleared Oct 13, 2016
Sunmed Haemostatic Valves
K153685
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular · 296d
Cleared Oct 06, 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
K161584
Asahi Intecc Co., Ltd.
Cardiovascular · 120d
Cleared Sep 20, 2016
Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip
K161887
Volcano Corporation
Cardiovascular · 71d
Cleared Aug 18, 2016
S-Wire Guidewire System
K153397
Concert Medical, LLC
Cardiovascular · 268d
Cleared Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Jun 13, 2016
Arrow Quickflash Arterial Catheterization Device
K160018
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Cardiovascular · 160d
Cleared Feb 25, 2016
ASAHI Astato XS 40
K153443
Asahi Intecc Co., Ltd.
Cardiovascular · 90d
Cleared Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
K152231
Boston Scientific Corporation
Cardiovascular · 189d
Cleared Feb 11, 2016
OptoWire Deux
K152991
Opsens
Cardiovascular · 121d
Cleared Jan 22, 2016
PW Guidewires
K152497
Tatara Vascular, LLC
Cardiovascular · 143d
Cleared Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
K151840
Boston Scientific Corporation
Cardiovascular · 163d
Cleared Nov 18, 2015
R350 guidewire
K151234
Vascular Solutions, Inc.
Cardiovascular · 194d
Cleared Nov 16, 2015
Radifocus Glidewire
K152740
Ashitaka Factory of Terumo Corp.
Cardiovascular · 54d
Cleared Oct 21, 2015
HI-TORQUE BALANCE
K152709
Abbott Vascular
Cardiovascular · 30d