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 Abbott Medical, CenterPoint Systems, LLC and OrbusNeich Medical (Shenzhen) Co., Ltd..
FDA 510(k) Cleared Catheter, Percutaneous Devices (Product Code DQY)
About Product Code DQY - Regulatory Context
510(k) Submission Activity
888 total 510(k) submissions under product code DQY since 1979, with 888 receiving FDA clearance (average review time: 104 days).
Submission volume has remained relatively stable over the observed period, with 35 submissions in the last 24 months.
FDA Review Time
FDA review times for DQY submissions have been consistent, averaging 115 days recently vs 104 days historically.
DQY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →