FDA 510(k) Applications Submitted by Avinger, Inc.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120273 |
01/30/2012 |
KITTYCAT CATHETER, KITTYCAT 2 CATHETER |
AVINGER, INC. |
| K122380 |
08/06/2012 |
OCELOT SYSTEM |
AVINGER, INC. |
| K123462 |
11/09/2012 |
OCELOT CATHETER |
AVINGER, INC. |
| K123532 |
11/16/2012 |
OCELOT PIXL CATHETER |
AVINGER, INC. |
| K160827 |
03/25/2016 |
Pantheris Catheter |
AVINGER, INC. |
| K101647 |
06/11/2010 |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 |
AVINGER, INC. |
| K102022 |
07/19/2010 |
WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S |
AVINGER, INC. |
| K083313 |
11/10/2008 |
WILDCAT 7F GUIDEWIRE SUPPORT CATHETER |
AVINGER, INC. |
| K111338 |
05/12/2011 |
WILDCAT CATHETER |
AVINGER, INC. |
| K152275 |
08/12/2015 |
Pantheris System |
Avinger, Inc. |
| K163264 |
11/21/2016 |
Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled |
Avinger, Inc. |
| K153460 |
12/01/2015 |
Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) |
AVINGER, INC. |
| K112579 |
09/06/2011 |
WILDCAT 5F GUIDEWIRE SUPPORT CATHETER |
AVINGER, INC. |
| K113838 |
12/28/2011 |
WILDCAT CATHETER |
AVINGER, INC. |
| K111704 |
06/17/2011 |
AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX |
AVINGER, INC. |
| K140185 |
01/24/2014 |
OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE |
AVINGER, INC. |
| K230005 |
01/03/2023 |
Pantheris LV Atherectomy Catheter |
Avinger, Inc. |
| K230594 |
03/03/2023 |
Tigereye ST CTO-Crossing Catheter |
Avinger, Inc. |
| K201330 |
05/19/2020 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
| K212047 |
06/30/2021 |
Pantheris System |
Avinger, Inc. |
| K172236 |
07/25/2017 |
Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled |
Avinger, Inc. |
| K212468 |
08/06/2021 |
Tigereye CTO-Crossing Catheter |
Avinger, Inc. |
| K182341 |
08/28/2018 |
Pantheris SV |
Avinger, Inc. |
| K173862 |
12/20/2017 |
Pantheris System |
Avinger, Inc. |
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