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., Terumo Corporation and Verge Medical, Inc..