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VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits

AngioDynamics, Inc.

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

AngioDynamics, Inc.
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
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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

3

K231945 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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