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The Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

The Vein360 Endovenous RFA Catheter is a reprocessed single-use device (SUD) consisting of a molded handle with actuation switch, an integrated instrument cable, and a flexible catheter shaft with a radiofrequency (RF) heating element at the distal end. The catheter and integrated connection cable are provided sterile and meant for single patient use. The catheter's function is to provide thermal energy to the desired treatment site via RF heating of the heating element and to relay temperature back to the RF generator. The Vein360 Endovenous RFA Catheter is subjected to reprocessing operations following the initial clinical use of the OEM predicate. These operations include cleaning, inspection, packaging and sterilization. After reprocessing, the Vein360 reprocessed Endovenous RFA Catheter retains substantially equivalent performance to that of the OEM predicate. The Vein360 reprocessed Endovenous RFA Catheter is reprocessed one (1) time.