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., Abbott Medical and Baylis Medical Company, Inc..

21
Total
21
Cleared
191d
Avg days
2021
Since

List of Wire, Guide, Catheter devices cleared through 510(k)

21 devices
1–21 of 21
Cleared Oct 03, 2025
Amplatzer Guidewire
K250031
Abbott Medical
Cardiovascular · 269d
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 Nov 06, 2024
Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire
K240997
Abbott Medical
Cardiovascular · 209d
Cleared Sep 18, 2024
Arrow® Nitinol Wire
K241784
Teleflex Medical
Cardiovascular · 90d
Cleared Aug 14, 2024
CROSSLEAD Tracker
K241510
Asahi Intecc Co., Ltd.
Cardiovascular · 77d
Cleared Jun 21, 2024
MINAMO blue
K240387
Asahi Intecc Co., Ltd.
Cardiovascular · 134d
Cleared Oct 28, 2023
Mighty Wire Guide Wire
K230418
Merit Medical Systems, Inc.
Cardiovascular · 254d
Cleared Oct 24, 2023
Steerant™ Super Stiff Guidewire
K232570
Medtronic Vascular
Cardiovascular · 61d
Cleared Jul 20, 2023
CROSSLEAD Penetration Peripheral Guide Wire
K230377
Asahi Intecc Co., Ltd.
Cardiovascular · 157d
Cleared Mar 01, 2023
ProTrack Pigtail Wire
K213898
Baylis Medical Company, Inc.
Cardiovascular · 442d
Cleared Dec 19, 2022
Mechanical Guidewire
K221351
Baylis Medical Company, Inc.
Cardiovascular · 223d
Cleared Sep 06, 2022
ASAHI Gladius Mongo18 PV ES
K213868
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Jul 01, 2022
CROSSLEAD Peripheral Guide Wire
K213315
Asahi Intecc Co., Ltd.
Cardiovascular · 270d
Cleared Dec 08, 2021
ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20
K211898
Asahi Intecc Co., Ltd.
Cardiovascular · 170d
Cleared Apr 15, 2021
Verrata PLUS Pressure Guide Wire
K210235
Volcano Corporation
Cardiovascular · 77d

How to use this database

This page lists all FDA 510(k) submissions for Wire, Guide, Catheter devices (product code DQX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.

These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →