FDA Product Code QEY: Mechanical Thrombolysis Catheter
Mechanical thrombolysis augments aspiration with active clot disruption. FDA product code QEY covers mechanical thrombolysis catheters used in peripheral and coronary vessels.
These devices use high-velocity fluid jets, rotating elements, or acoustic energy to mechanically fragment thrombus while simultaneously aspirating the debris, enabling more complete clot removal than aspiration alone in acute arterial and venous occlusions.
QEY devices are Class II medical devices, regulated under 21 CFR 870.5150 and reviewed by the FDA Cardiovascular panel.
Leading manufacturers include Boston Scientific, Liquet Medical, Inc. and Boston Scientific Corporation.
FDA 510(k) Cleared Mechanical Thrombolysis Catheter Devices (Product Code QEY)
About Product Code QEY - Regulatory Context
510(k) Submission Activity
71 total 510(k) submissions under product code QEY since 1995, with 71 receiving FDA clearance (average review time: 79 days).
Submission volume has increased in recent years - 3 submissions in the last 24 months compared to 2 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under QEY have taken an average of 148 days to reach a decision - up from 76 days historically. Manufacturers should account for longer review timelines in current project planning.
QEY devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →