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Avinger, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
25
Inspections
3
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K230005Pantheris LV Atherectomy CatheterJune 6, 2023
K230594Tigereye ST CTO-Crossing CatheterApril 25, 2023
K212468Tigereye CTO-Crossing CatheterJanuary 6, 2022
K212047Pantheris SystemNovember 16, 2021
K201330Tigereye CTO-Crossing CatheterSeptember 10, 2020
K182341Pantheris SVApril 9, 2019
K173862Pantheris SystemMay 22, 2018
K172236Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox SledOctober 30, 2017
K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledDecember 21, 2016
K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledOctober 18, 2016
K160827Pantheris CatheterApril 21, 2016
K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)March 1, 2016
K152275Pantheris SystemOctober 14, 2015
K140185OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLEMay 1, 2014
K123532OCELOT PIXL CATHETERDecember 14, 2012
K123462OCELOT CATHETERDecember 7, 2012
K122380OCELOT SYSTEMNovember 7, 2012
K120273KITTYCAT CATHETER, KITTYCAT 2 CATHETERMarch 30, 2012
K113838WILDCAT CATHETERMarch 12, 2012
K112579WILDCAT 5F GUIDEWIRE SUPPORT CATHETEROctober 6, 2011