Company ยท US
Avinger, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2009 to 2023. Name variants (Inc, Corp, punctuation) are merged.
25510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 6, 2023 | K230005 | Pantheris LV Atherectomy Catheter Avinger, Inc. | MCW |
| Apr 25, 2023 | K230594 | Tigereye ST CTO-Crossing Catheter Avinger, Inc. | PDU |
| Jan 6, 2022 | K212468 | Tigereye CTO-Crossing Catheter Avinger, Inc. | PDU |
| Nov 16, 2021 | K212047 | Pantheris System Avinger, Inc. | MCW |
| Sep 10, 2020 | K201330 | Tigereye CTO-Crossing Catheter Avinger, Inc. | PDU |
| Apr 9, 2019 | K182341 | Pantheris SV Avinger, Inc. | MCW |
| May 22, 2018 | K173862 | Pantheris System Avinger, Inc. | MCW |
| Oct 30, 2017 | K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled Avinger, Inc. | MCW |
| Dec 21, 2016 | K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled Avinger, Inc. | MCW |
| Oct 18, 2016 | K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled Avinger, Inc. | MCW |
| Apr 21, 2016 | K160827 | Pantheris Catheter Avinger, Inc. | MCW |
| Mar 1, 2016 | K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) Avinger, Inc. | MCW |
| Oct 14, 2015 | K152275 | Pantheris System Avinger, Inc. | MCW |
| May 1, 2014 | K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE Avinger, Inc. | PDU |
| Dec 14, 2012 | K123532 | OCELOT PIXL CATHETER Avinger, Inc. | PDU |
| Dec 7, 2012 | K123462 | OCELOT CATHETER Avinger, Inc. | PDU |
| Nov 7, 2012 | K122380 | OCELOT SYSTEM Avinger, Inc. | PDU |
| Mar 30, 2012 | K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER Avinger, Inc. | PDU |
| Mar 12, 2012 | K113838 | WILDCAT CATHETER Avinger, Inc. | PDU |
| Oct 6, 2011 | K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. | DQY |
| Sep 9, 2011 | K111704 | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX Avinger, Inc. | DQY |
| Aug 11, 2011 | K111338 | WILDCAT CATHETER Avinger, Inc. | PDU |
| Aug 6, 2010 | K102022 | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S Avinger, Inc. | DQY |
| Aug 6, 2010 | K101647 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 Avinger, Inc. | DQY |
| Feb 2, 2009 | K083313 | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER Avinger, Inc. | DQY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||