# Vein 360, LLC

- Location (FDA's records): Blue Ash, OH
- FDA decisions: 5 (2019–2026): 5 510(k) clearances
- Names in FDA's records: Vein 360, LLC (4); Vein 360 (1)
- Product codes: OWQ (3), NUJ (1), FGB (1)
- 510(k) review time since 2016: median 120 days, against 78 for FDA's reviews in the same codes and years (1 of 4 faster)
- Predicates its devices cite: 6 (0 its own); citations of its devices by later devices: 0 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Volcano Corporation: 4 (https://510kreport.com/company/volcano)
- Vnus Medical Technologies, Inc.: 1 (https://510kreport.com/company/vnus-medical-technologies)
- Covidien: 1 (https://510kreport.com/company/covidien)

## Recent decisions
- K260708: Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection) (Oct 20, 2026)
- K232584: Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter (Oct 24, 2023)
- K230928: Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (Aug 25, 2023)
- K230584: Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter (Jun 6, 2023)
- K191073: Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter (Oct 22, 2019)

Source page: https://510kreport.com/company/vein-360