Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits are indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity.
The VenaCure EVLT Tre' Sheath and VenaCure EVLT NeverTouch Procedure Kits include a variety of procedural accessories: NeverTouch Fiber with Sheath-Loc Fitting, Tre' Sheath Introducer with Dilator, Teflon Coated Stainless Steel Guidewire (lengths from 70cm to 200cm), 0.018 Guidewire (Lengths from 45cm to 200cm), Micro Access Components: 21 gauge Entry Needle, 5F x 10cm Sheath/Dilator, 0.018" x 45cm Guidewire, 19 gauge Entry Needle (optional). The VenaCure EVLT Tre' Sheath is a 4F sheath used during endovascular venous laser treatment procedures. The sheath is used as a conduit for placing a laser fiber. The product will be offered in 25, 45, 65, and 90cm lengths. The VenaCure EVLT Tre' Sheath will be provided both as a standalone product and also packaged with the various procedural accessories detailed above.
Summary parsed at:2026-06-01 06:00:26 UTC
