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..

769
Total
769
Cleared
116d
Avg days
1976
Since
Growing category - 25 submissions in the last 2 years vs 19 in the prior period
Review times increasing: avg 178d recently vs 114d historically

FDA 510(k) Cleared Wire, Guide, Catheter Devices (Product Code DQX)

769 devices
1–24 of 769
Cleared Oct 16, 2026
Small Diameter Core Wire (CMAN-000-00)
K260168
Skycade Med Corporation
Cardiovascular · 269d
Cleared Sep 18, 2026
Hyperdrive 35 Guidewire
K253146
Rapid Medical , Ltd.
Cardiovascular · 358d
Cleared Sep 03, 2026
CROSSLEAD Standard 035 and CROSSLEAD Stiff 035
K261281
Filmecc Co., Ltd.
Cardiovascular · 139d
Cleared Jul 14, 2026
Accoat Guide Wire
K253667
Sp Medical A/S
Cardiovascular · 235d
Cleared Jul 13, 2026
Merit MAK Nitinol/Gold-Tungsten Guide Wire
K261640
Merit Medical Ireland, Ltd.
Cardiovascular · 56d
Cleared May 22, 2026
InQwire Amplatz Guide Wire
K254137
Merit Medical Ireland, Ltd.
Cardiovascular · 151d
Cleared Mar 20, 2026
FMD Peripheral Guide Wire F-14 Flex 6
K260544
FMD Co., Ltd.
Cardiovascular · 30d
Cleared Mar 19, 2026
Enroute 0.014'' Transcarotid Guidewire
K253746
Lake Region Medical
Cardiovascular · 114d
Cleared Mar 06, 2026
EmeryGlide™ (EG18008901)
K253262
Nano4imaging GmbH
Cardiovascular · 158d
Cleared Jan 31, 2026
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
K253847
Merit Medical Ireland, Ltd.
Cardiovascular · 60d
Cleared Jan 21, 2026
InQwire Super Stiff Guide Wire (IQSS32180J3)
K251385
Merit Medical Ireland, Ltd.
Cardiovascular · 261d
Cleared Jan 09, 2026
Solo Pace Fusion System (SOLOFUSE1)
K252674
Solo Pace, Inc.
Cardiovascular · 137d
Cleared Nov 09, 2025
Lunderquist Extra Stiff Wire Guide
K251596
William Cook Europe Aps
Cardiovascular · 166d
Cleared Oct 17, 2025
SureAx-Guide™
K250203
Sureax Medical, LLC
Cardiovascular · 266d
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031
Abbott Medical
Cardiovascular · 269d
Cleared Aug 29, 2025
Splashwire Hydrophilic Guide Wire (MSWSTD35180J1O5)
K251181
Merit Medical Ireland, Ltd.
Cardiovascular · 135d
Cleared Jul 25, 2025
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K250552
Abbott Medical
Cardiovascular · 150d
Cleared Jun 13, 2025
Medtronic Stedi Extra Support Guidewire
K250075
Medtronic, Inc.
Cardiovascular · 154d
Cleared Apr 02, 2025
SION blue PLUS
K243733
Asahi Intecc Co., Ltd.
Cardiovascular · 119d
Cleared Mar 27, 2025
Crossloop
K241962
Asahi Intecc Co., Ltd.
Cardiovascular · 267d
Cleared Mar 05, 2025
CROSSLEAD 0.018inch
K242597
Asahi Intecc Co., Ltd.
Cardiovascular · 187d
Cleared Feb 06, 2025
CROSSLEAD 0.014inch
K241702
Asahi Intecc Co., Ltd.
Cardiovascular · 238d
Cleared Dec 10, 2024
Prelude Small O.D. Introducer Guide Wire
K241521
Merit Medical Systems, Inc.
Cardiovascular · 195d
Cleared Dec 06, 2024
PTFE Guidewire
K242824
Lake Region Medical
Cardiovascular · 79d

About Product Code DQX - Regulatory Context

510(k) Submission Activity

769 total 510(k) submissions under product code DQX since 1976, with 769 receiving FDA clearance (average review time: 116 days).

Submission volume has increased in recent years - 25 submissions in the last 24 months compared to 19 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DQX Product Code

Recent submissions under DQX have taken an average of 178 days to reach a decision - up from 114 days historically. Manufacturers should account for longer review timelines in current project planning.

DQX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →