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
Apr 03, 2017
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
Asahi Intecc Co., Ltd.
Cardiovascular
118d
Cleared
Mar 22, 2017
Fathom-16 Steerable Guidewires
Boston Scientific Corporation
Cardiovascular
20d
Cleared
Mar 03, 2017
Inqwire Diagnostic Guide Wire
Merit Medical Systems, Inc.
Cardiovascular
74d
Cleared
Jan 30, 2017
Radifocus Glidewire Advantage Track
Ashitaka Factory of Terumo Coporation
Cardiovascular
94d
Cleared
Jan 27, 2017
ASAHI PTCA Guide Wire ASAHI SUOH 03
Asahi Intecc Co., Ltd.
Cardiovascular
108d
Cleared
Jan 06, 2017
Spectre guidewire
Vascular Solutions, Inc.
Cardiovascular
29d
Cleared
Dec 08, 2016
Worker Guidewire
Argon Medical Devices, Inc.
Cardiovascular
261d
Cleared
Dec 06, 2016
Endura guidewire
Vascular Solutions, Inc.
Cardiovascular
169d
Cleared
Nov 22, 2016
MRWire Guide Wire
Nano4imaging GmbH
Cardiovascular
266d
Cleared
Oct 18, 2016
ENROUTE 0.014 Guidewire
Lake Region Medical
Cardiovascular
225d
Cleared
Oct 13, 2016
Sunmed Haemostatic Valves
Sunny Medical Device (Shenzhen) Co., Ltd.
Cardiovascular
296d
Cleared
Oct 06, 2016
ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16
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
Volcano Corporation
Cardiovascular
71d
Cleared
Aug 18, 2016
S-Wire Guidewire System
Concert Medical, LLC
Cardiovascular
268d
Cleared
Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
Asahi Intecc Co., Ltd.
Cardiovascular
238d
Cleared
Jun 13, 2016
Arrow Quickflash Arterial Catheterization Device
Arrow International, Inc. (Subsidiary of Teleflex, Inc.)
Cardiovascular
160d
Cleared
Feb 25, 2016
ASAHI Astato XS 40
Asahi Intecc Co., Ltd.
Cardiovascular
90d
Cleared
Feb 12, 2016
Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire
Boston Scientific Corporation
Cardiovascular
189d
Cleared
Feb 11, 2016
OptoWire Deux
Opsens
Cardiovascular
121d
Cleared
Jan 22, 2016
PW Guidewires
Tatara Vascular, LLC
Cardiovascular
143d
Cleared
Dec 16, 2015
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
Boston Scientific Corporation
Cardiovascular
163d
Cleared
Nov 18, 2015
R350 guidewire
Vascular Solutions, Inc.
Cardiovascular
194d
Cleared
Nov 16, 2015
Radifocus Glidewire
Ashitaka Factory of Terumo Corp.
Cardiovascular
54d
Cleared
Oct 21, 2015
HI-TORQUE BALANCE
Abbott Vascular
Cardiovascular
30d