# K061373: Vnus Closurefast Catheter, Models CF7-7-60 and CF7-7-100

- Pathway: 510(k) (Traditional)
- Applicant: Vnus Medical Technologies, Inc.
- Decided: Aug 1, 2006 after 76 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K943450 (1995). 23 ancestors in all.
13 later devices descend from it; 6 cite it directly.
0 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030557: Modification to Vnus Closure System, Vnus Medical Technologies, Inc. (2003) Summary page 1.

## Most influential descendants
- K111887: Closurefast Radiofrequency Catheter (2011), 6 descendants of its own
- K160754: Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) (2016), 3 descendants of its own
- K211806: Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter (2021), 2 descendants of its own
- K250068: Venclose digiRF Generator (VCRFG1) (2025), 1 descendant of its own
- K253918: Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) (2026), 0 descendants of its own

## Recalls of this device
- Aug 8, 2007 · Not classified · Z-0542-2008: Instructions for Use change: Instructions for Use have been changed to include a modified placement recommendation.
- Mar 6, 2007 · Not classified · Z-0132-2008: Sterility (package integrity) Compromised: Product sterility may be compromised due to a pinhole under the pouch foldover.

## Indications for use
The VNUS ® ClosureFASTTM Catheter is intended for endovascular coagulation of blood vessels in patients with superficial vein reflux.

Source page: https://510kreport.com/device/K061373
Methodology: https://510kreport.com/methodology