FDA Product Code LOX: Catheters, Transluminal Coronary Angioplasty, Percutaneous
Percutaneous coronary angioplasty is the cornerstone of interventional cardiology. FDA product code LOX covers coronary angioplasty catheters for transluminal balloon dilation.
These balloon catheters are advanced over a guidewire to the site of coronary stenosis and inflated at high pressure to compress plaque and dilate the obstructed artery, restoring blood flow to ischemic myocardium in acute coronary syndrome and stable angina.
LOX devices are Class II medical devices, regulated under 21 CFR 870.5100 and reviewed by the FDA Hematology panel.
Leading manufacturers include OrbusNeich Medical (Shenzhen) Co., Ltd., Boston Scientific and Abbott Vascular.
FDA 510(k) Cleared Catheters, Transluminal Coronary Angioplasty, Percutaneous Devices (Product Code LOX)
About Product Code LOX - Regulatory Context
510(k) Submission Activity
86 total 510(k) submissions under product code LOX since 1982, with 86 receiving FDA clearance (average review time: 139 days).
Submission volume has increased in recent years - 8 submissions in the last 24 months compared to 6 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under LOX have taken an average of 204 days to reach a decision - up from 133 days historically. Manufacturers should account for longer review timelines in current project planning.
LOX devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →