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
97–120 of 766
Cleared Mar 30, 2018
Mandril Wire Guide
K171997
Cook Incorporated
Cardiovascular · 270d
Cleared Mar 19, 2018
Double Flexible Tip Wire Guides
K171912
Cook Incorporated
Cardiovascular · 266d
Cleared Mar 09, 2018
Fixed Core Wire Guides
K171764
Cook Incorporated
Cardiovascular · 268d
Cleared Feb 16, 2018
Warrior 14 guidewire
K180128
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Feb 12, 2018
ASAHI PTCA Guide Wires, ASAHI Corsair Microcatheter, ASAHI Corsair Pro Microcatheter
K171933
Asahi Intecc Co., Ltd.
Cardiovascular · 229d
Cleared Jan 22, 2018
Aristotle 14 Guidewire, 200cm, Soft Profile, Aristotle 14 Guidewire, 200cm, Support Profile, Aristotle 14 Guidewire, 300cm, Soft Profile, Aristotle 14 Guidewire, 300cm, Support Profile
K173235
Scientia Vascular, LLC
Cardiovascular · 109d
Cleared Jan 12, 2018
HI-TORQUE TurnTrac Guide Wire Family
K173795
Abbott Vascular
Cardiovascular · 29d
Cleared Jan 10, 2018
Amplatz Support Wire Guide with Apex Curve
K171445
Cook Incorporated
Cardiovascular · 239d
Cleared Jan 05, 2018
Roadrunner Extra Support Wire Guide
K171948
Cook Incorporated
Cardiovascular · 190d
Cleared Dec 15, 2017
Raider Guidewire
K173532
Vascular Solutions, Inc.
Cardiovascular · 30d
Cleared Nov 09, 2017
WATCHDOG Hemostasis Valve Kit
K172453
Boston Scientific Corporation
Cardiovascular · 87d
Cleared Aug 21, 2017
Approach CTO Microwire Guide
K171897
Cook Incorporated
Cardiovascular · 56d
Cleared Jul 21, 2017
True Form Reshapable Guide Wire
K170532
Merit Medical Systems, Inc.
Cardiovascular · 149d
Cleared Jun 22, 2017
Merit Hydrophilic Guide Wire
K170933
Merit Medical Systems, Inc.
Cardiovascular · 85d
Cleared Apr 06, 2017
Inqwire Diagnostic Guide Wire
K170700
Merit Medical Systems, Inc.
Cardiovascular · 30d
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 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 06, 2016
Endura guidewire
K161702
Vascular Solutions, Inc.
Cardiovascular · 169d
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 Jun 21, 2016
ASAHI Fielder XT-A, ASAHI Fielder XT-R
K153106
Asahi Intecc Co., Ltd.
Cardiovascular · 238d