FDA Product Code DQY: Catheter, Percutaneous
Percutaneous catheters are foundational tools in interventional cardiology and vascular medicine. FDA product code DQY covers catheters designed for percutaneous access to the vascular system.
These devices enable clinicians to navigate blood vessels to deliver therapies, measure pressures, or access cardiac structures without open surgery. They are used in angioplasty, electrophysiology, structural heart procedures, and hemodynamic monitoring.
DQY devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Medtronic Vascular, Cordis Corp. and C.R. Bard, Inc..
FDA 510(k) Cleared Catheter, Percutaneous Devices (Product Code DQY)
About Product Code DQY - Regulatory Context
510(k) Submission Activity
889 total 510(k) submissions under product code DQY since 1979, with 889 receiving FDA clearance (average review time: 104 days).
Submission volume has remained relatively stable over the observed period, with 34 submissions in the last 24 months.
FDA 510(k) Review Time - DQY Product Code
Recent submissions under DQY have taken an average of 119 days to reach a decision - up from 103 days historically. Manufacturers should account for longer review timelines in current project planning.
DQY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →