Manufacturer
AngioDynamics, Inc.VenaCure EVLT NeverTouch Procedure Kit
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K171921
- Device name
- VenaCure EVLT NeverTouch Procedure Kit
- Company
- AngioDynamics, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2017-06-27
- Decision date
- 2017-08-24
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1VenaCure EVLT NeverTouch Procedure Kit
K171921 references 1 predicate/reference device
Cited as predicate
1VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
1 submission cite K171921 as a predicate
