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Avinger, Inc.

FDA 510(k) & PMA Approved Devices — 23 products

Total Devices23
Categories0
Latest FDA decision
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
510(k) K123532 OCELOT PIXL CATHETERPDU2012-12-14 View
510(k) K123462 OCELOT CATHETERPDU2012-12-07 View
510(k) K122380 OCELOT SYSTEMPDU2012-11-07 View
510(k) K120273 KITTYCAT CATHETER, KITTYCAT 2 CATHETERPDU2012-03-30 View
510(k) K113838 WILDCAT CATHETERPDU2012-03-12 View
510(k) K112579 WILDCAT 5F GUIDEWIRE SUPPORT CATHETERDQY2011-10-06 View
510(k) K111704 AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOXDQY2011-09-09 View
510(k) K111338 WILDCAT CATHETERPDU2011-08-11 View
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