Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Vein 360 with 5 510(k) clearances. The most recent is a 510(k) clearance dated Oct 20, 2026: Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein36….
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 20, 2026 | Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Standard Deflection); Vein360 Reprocessed LithoVue Digital Flexible Ureteroscope (Reverse Deflection)K260708 · FGB | 510(k) clearances |
| Oct 24, 2023 | 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 CatheterK232584 · OWQ | 510(k) clearances |
| Aug 25, 2023 | Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterK230928 · OWQ | 510(k) clearances |
| Jun 6, 2023 | Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterK230584 · OWQ | 510(k) clearances |
| Oct 22, 2019 | Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterK191073 · NUJ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
