Avinger, Inc.
Avinger, Inc. appears in FDA public data with 0 recalls, 25 510(k) clearances, 3 FDA inspections, and 0 compliance actions on record. Its most recent 510(k) clearance was granted on Jun 6, 2023.
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 25
- Inspections
- 3
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K230005 | Pantheris LV Atherectomy Catheter | Jun 6, 2023 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Apr 25, 2023 |
| K212468 | Tigereye CTO-Crossing Catheter | Jan 6, 2022 |
| K212047 | Pantheris System | Nov 16, 2021 |
| K201330 | Tigereye CTO-Crossing Catheter | Sep 10, 2020 |
| K182341 | Pantheris SV | Apr 9, 2019 |
| K173862 | Pantheris System | May 22, 2018 |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | Oct 30, 2017 |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | Dec 21, 2016 |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | Oct 18, 2016 |
| K160827 | Pantheris Catheter | Apr 21, 2016 |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Mar 1, 2016 |
| K152275 | Pantheris System | Oct 14, 2015 |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | May 1, 2014 |
| K123532 | OCELOT PIXL CATHETER | Dec 14, 2012 |
| K123462 | OCELOT CATHETER | Dec 7, 2012 |
| K122380 | OCELOT SYSTEM | Nov 7, 2012 |
| K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER | Mar 30, 2012 |
| K113838 | WILDCAT CATHETER | Mar 12, 2012 |
| K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER | Oct 6, 2011 |