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 Merit Medical Ireland, Ltd..
FDA 510(k) Cleared Wire, Guide, Catheter Devices (Product Code DQX)
About Product Code DQX - Regulatory Context
510(k) Submission Activity
763 total 510(k) submissions under product code DQX since 1976, with 763 receiving FDA clearance (average review time: 116 days).
Submission volume has increased in recent years - 27 submissions in the last 24 months compared to 22 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under DQX have taken an average of 160 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 →