Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Avinger with 25 510(k) clearances. The most recent is a 510(k) clearance dated Jun 6, 2023: Pantheris LV Atherectomy Catheter.
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.
| Jun 6, 2023 | Pantheris LV Atherectomy CatheterK230005 · MCW | 510(k) clearances |
| Apr 25, 2023 | Tigereye ST CTO-Crossing CatheterK230594 · PDU | 510(k) clearances |
| Jan 6, 2022 | Tigereye CTO-Crossing CatheterK212468 · PDU | 510(k) clearances |
| Nov 16, 2021 | Pantheris SystemK212047 · MCW | 510(k) clearances |
| Sep 10, 2020 | Tigereye CTO-Crossing CatheterK201330 · PDU | 510(k) clearances |
| Apr 9, 2019 | Pantheris SVK182341 · MCW | 510(k) clearances |
| May 22, 2018 | Pantheris SystemK173862 · MCW | 510(k) clearances |
| Oct 30, 2017 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledK172236 · MCW | 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
