Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Avinger, Inc. — Predicate Candidate Screening
25 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
84 daysmedian FDA review time
153 days90th percentile
25clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K230005 | Pantheris LV Atherectomy Catheter | Avinger, Inc. | 2023-06-06 | 154 | 0 |
| K230594 | Tigereye ST CTO-Crossing Catheter | Avinger, Inc. | 2023-04-25 | 53 | 0 |
| K212468 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2022-01-06 | 153 | 0 |
| K212047 | Pantheris System | Avinger, Inc. | 2021-11-16 | 139 | 0 |
| K201330 | Tigereye CTO-Crossing Catheter | Avinger, Inc. | 2020-09-10 | 114 | 0 |
| K182341 | Pantheris SV | Avinger, Inc. | 2019-04-09 | 224 | 0 |
| K173862 | Pantheris System | Avinger, Inc. | 2018-05-22 | 153 | 0 |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox H | Avinger, Inc. | 2017-10-30 | 97 | 0 |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS | Avinger, Inc. | 2016-12-21 | 30 | 0 |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sl | Avinger, Inc. | 2016-10-18 | 60 | 0 |
| K160827 | Pantheris Catheter | Avinger, Inc. | 2016-04-21 | 27 | 0 |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | Avinger, Inc. | 2016-03-01 | 91 | 0 |
| K152275 | Pantheris System | Avinger, Inc. | 2015-10-14 | 63 | 0 |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | Avinger, Inc. | 2014-05-01 | 97 | 0 |
| K123532 | OCELOT PIXL CATHETER | Avinger, Inc. | 2012-12-14 | 28 | 0 |
| K123462 | OCELOT CATHETER | Avinger, Inc. | 2012-12-07 | 28 | 0 |
| K122380 | OCELOT SYSTEM | Avinger, Inc. | 2012-11-07 | 93 | 0 |
| K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER | Avinger, Inc. | 2012-03-30 | 60 | 0 |
| K113838 | WILDCAT CATHETER | Avinger, Inc. | 2012-03-12 | 75 | 0 |
| K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER | Avinger, Inc. | 2011-10-06 | 30 | 0 |
| K111704 | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX | Avinger, Inc. | 2011-09-09 | 84 | 0 |
| K111338 | WILDCAT CATHETER | Avinger, Inc. | 2011-08-11 | 91 | 0 |
| K102022 | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S | Avinger, Inc. | 2010-08-06 | 18 | 0 |
| K101647 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 | Avinger, Inc. | 2010-08-06 | 56 | 0 |
| K083313 | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER | Avinger, Inc. | 2009-02-02 | 84 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda