Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The 400μm Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial vein perforator veins.
The 400μm Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of Incompetent (i.e. refluxing) Perforator Veins (IPVs).
The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in 'pile-up' of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400μm Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components: 21G Entry Needle, 4F Introducer Sheath/Dilator, 0.018" Guidewire. The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.
Summary parsed at:2026-06-01 05:57:33 UTC
