Avinger, Inc. - FDA 510(k) Cleared Devices
Recent clearances: Pantheris LV Atherectomy Catheter, Tigereye ST CTO-Crossing Catheter, Tigereye CTO-Crossing Catheter
25
Total
25
Cleared
0
Denied
FDA 510(k) Regulatory Record - Avinger, Inc. Cardiovascular ✕
25 devices
Cleared
Jun 06, 2023
Pantheris LV Atherectomy Catheter
Cardiovascular
154d
Cleared
Apr 25, 2023
Tigereye ST CTO-Crossing Catheter
Cardiovascular
53d
Cleared
Jan 06, 2022
Tigereye CTO-Crossing Catheter
Cardiovascular
153d
Cleared
CT
Nov 16, 2021
Pantheris System
Cardiovascular
139d
Cleared
Sep 10, 2020
Tigereye CTO-Crossing Catheter
Cardiovascular
114d
Cleared
Apr 09, 2019
Pantheris SV
Cardiovascular
224d
Cleared
May 22, 2018
Pantheris System
Cardiovascular
153d
Cleared
Oct 30, 2017
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging...
Cardiovascular
97d
Cleared
Dec 21, 2016
Pantheris Catheter (8F)
Cardiovascular
30d
Cleared
Oct 18, 2016
Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled
Cardiovascular
60d
Cleared
Apr 21, 2016
Pantheris Catheter
Cardiovascular
27d
Cleared
Mar 01, 2016
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)
Cardiovascular
91d