Avinger, Inc.

Medical device manufacturer in Redwood City, CA.

25510(k) clearances
0PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K230005Pantheris LV Atherectomy CatheterMCW · Traditional 06/06/2023SE
K230594Tigereye ST CTO-Crossing CatheterPDU · Traditional 04/25/2023SE
K212468Tigereye CTO-Crossing CatheterPDU · Traditional 01/06/2022SE
K212047Pantheris SystemMCW · Traditional 11/16/2021SE
K201330Tigereye CTO-Crossing CatheterPDU · Traditional 09/10/2020SE
K182341Pantheris SVMCW · Traditional 04/09/2019SE
K173862Pantheris SystemMCW · Traditional 05/22/2018SE
K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox…MCW · Special 10/30/2017SE
K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledMCW · Special 12/21/2016SE
K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledMCW · Traditional 10/18/2016SE
K160827Pantheris CatheterMCW · Special 04/21/2016SE
K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)MCW · Traditional 03/01/2016SE
K152275Pantheris SystemMCW · Traditional 10/14/2015SE
K140185Ocelot Catheter, Ocelot Pixl Catheter, Lightbox ConsolePDU · Traditional 05/01/2014SE
K123532Ocelot Pixl CatheterPDU · Special 12/14/2012SE
K123462Ocelot CatheterPDU · Special 12/07/2012SE
K122380Ocelot SystemPDU · Traditional 11/07/2012SE
K120273Kittycat Catheter, Kittycat 2 CatheterPDU · Traditional 03/30/2012SE
K113838Wildcat CatheterPDU · Traditional 03/12/2012SE
K112579Wildcat 5F Guidewire Support CatheterDQY · Special 10/06/2011SE
K111704Avinger Wildcat 6F Guidewire Support Catheter and JuiceboxDQY · Traditional 09/09/2011SE
K111338Wildcat CatheterPDU · Traditional 08/11/2011SE
K102022Wildcat 6F Guidewire Support Catheter Model W400L and W400SDQY · Special 08/06/2010SE
K101647Wildcat 5F Guidewire Support Catheter, Mode W500DQY · Special 08/06/2010SE
K083313Wildcat 7F Guidewire Support CatheterDQY · Traditional 02/02/2009SE