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Avinger, Inc.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories2
Latest FDA decision2023-06-06
TypeNumberDevice NameCodeDateActions
510(k) K230005 Pantheris LV Atherectomy CatheterMCW2023-06-06 View
510(k) K230594 Tigereye ST CTO-Crossing CatheterPDU2023-04-25 View
510(k) K212468 Tigereye CTO-Crossing CatheterPDU2022-01-06 View
510(k) K212047 Pantheris SystemMCW2021-11-16 View
510(k) K201330 Tigereye CTO-Crossing CatheterPDU2020-09-10 View
510(k) K182341 Pantheris SVMCW2019-04-09 View
510(k) K173862 Pantheris SystemMCW2018-05-22 View
510(k) K172236 Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledMCW2017-10-30 View
510(k) K163264 Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW2016-12-21 View
510(k) K162326 Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledMCW2016-10-18 View
510(k) K160827 Pantheris CatheterMCW2016-04-21 View
510(k) K153460 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)MCW2016-03-01 View
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