Manufacturer
AngioDynamics, Inc.VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K231945
- Device name
- VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits
- Company
- AngioDynamics, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-06-30
- Decision date
- 2023-07-20
- Submission type
- Special
- Technology type
- Laser fiber / delivery(AI inferred)
- Clinical applications
- Vascular treatmentOther
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The VenaCure EVLT NeverTouch Procedure Kit is 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 NeverTouch Direct Procedure Kit is 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 NeverTouch Direct Introducer Sheath is indicated for use with the VenaCure EVLT NeverTouch Direct Procedure Kit to introduce the laser fiber into the peripheral vasculature.
Intended Use
The VenaCure EVLT NeverTouch Procedure Kit is 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 NeverTouch Direct Procedure Kit is 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 NeverTouch and NeverTouch Direct Fiber Procedure Kits include single use disposable devices for use with a laser for the treatment of varicose veins. The main components of the NeverTouch Procedure Kit are identified below: 600µ VenaCure EVLT NeverTouch Fiber, 4Fr Tre' Sheath Introducer, 0.035" Guidewire, 19 Gauge or 21 Gauge Entry Needle. The VenaCure EVLT NeverTouch Direct Procedure Kits is comprised of single use disposable devices for use with a laser for the treatment of varicose veins. The VenaCure EVLT NeverTouch Direct Fiber Procedure Kits are comprised of 21 Gauge Entry Needle, 0.018" Guidewire, Introducer Sheath/Dilator Assembly, Fiber.
Summary parsed at:2026-06-01 05:33:12 UTC
Predicate devices
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Not ingested
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VenaCure EVLT NeverTouch Procedure Kit
K231945 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K231945 as a predicate