Manufacturer
AngioDynamics, Inc.400um Perforator and Accessory Vein Ablation Kit
Country / Region:United States (US)Submission type:Traditional
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
- K181044
- Device name
- 400um Perforator and Accessory Vein Ablation Kit
- Company
- AngioDynamics, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-04-19
- Decision date
- 2018-07-05
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The 400μm Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial vein perforator veins.
Intended Use
The 400μm Perforator and Accessory Vein Ablation Kit is indicated for use in the treatment of superficial vein reflux of greater saphenous vein associated with varicosities. The 400μm Perforator and Accessory Vein Ablation Kit is indicated for treatment of incompetence and reflux of superficial veins in the lower extremity, and for the treatment of Incompetent (i.e. refluxing) Perforator Veins (IPVs).
Device Description
The 400μm Perforator and Accessory Vein Ablation Kit is used to treat patients with varicose veins. Varicose veins are large, twisted, visibly bulging veins usually located in the legs. Varicose veins occur when either the blood flow is too slow or valves are not functioning correctly resulting in 'pile-up' of blood within the lower extremity veins. AngioDynamics proposes that this include the Incompetent Perforator Veins (IPVs). The 400μm Perforator and Accessory Vein Ablation Kit is provided in a procedure kit which includes a 400μm Fiber along with the following accessory components: 21G Entry Needle, 4F Introducer Sheath/Dilator, 0.018" Guidewire. The 400μm Perforator and Accessory Vein Ablation Kit is presented sterile and contains all of the accessories needed to perform the EVLT procedure, with the exception of generic disposable items routinely found in a well-equipped minor treatment room such as drapes, swabs, bandages etc.
Summary parsed at:2026-06-01 05:57:33 UTC
