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 Boston Scientific, Abbott Vascular and Biotronik, Inc..
List of Catheters, Transluminal Coronary Angioplasty, Percutaneous devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Catheters, Transluminal Coronary Angioplasty, Percutaneous devices (product code LOX). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Cardiovascular FDA review panel. Browse all Cardiovascular devices →