# K191073: Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Vein 360, LLC
- Decided: Oct 22, 2019 after 183 days
- Product code: NUJ (Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K943450 (1995). 25 ancestors in all.
No later device cites it as a predicate yet.
0 of 26 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061373: Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100, Vnus Medical Technologies, Inc. (2006) Summary page 6.
- K111887: Closurefast Radiofrequency Catheter, Covidien (2011) Summary page 6.

## Indications for use
The Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K191073
Methodology: https://510kreport.com/methodology