FDA Product Code LIT: Catheter, Angioplasty, Peripheral, Transluminal

Peripheral arterial disease affects millions of patients worldwide and can lead to limb-threatening ischemia. FDA product code LIT covers peripheral transluminal angioplasty catheters.

These balloon catheters are advanced through peripheral arteries and inflated at the site of stenosis to compress plaque and dilate the vessel lumen, restoring blood flow to the affected limb. They are used in the treatment of iliac, femoral, popliteal, and tibial artery disease.

LIT devices are Class II medical devices, regulated under 21 CFR 870.1250 and reviewed by the FDA Cardiovascular panel.

Leading manufacturers include Biotronik, Inc., Natec Medical , Ltd. and Boston Scientific Corporation.