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 Medtronic, Inc..
FDA 510(k) Cleared Catheter, Angioplasty, Peripheral, Transluminal Devices (Product Code LIT)
About Product Code LIT - Regulatory Context
510(k) Submission Activity
402 total 510(k) submissions under product code LIT since 1981, with 402 receiving FDA clearance (average review time: 114 days).
Submission volume has declined in recent years - 10 submissions in the last 24 months compared to 13 in the prior period.
FDA Review Time
Recent submissions under LIT have taken an average of 96 days to reach a decision - down from 115 days historically, suggesting improved FDA processing for this classification.
LIT devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →