Avinger, Inc.
Redwood City, CA, US
Avinger, Inc. appears in FDA device records in Redwood City, CA. FDA records list 25 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 25
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 25 510(k) clearances for Avinger, Inc. between 2009 and 2023. The busiest year on record is 2012, with 5. The most recent is 2023, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2009 | 1 |
| 2010 | 2 |
| 2011 | 3 |
| 2012 | 5 |
| 2014 | 1 |
| 2015 | 1 |
| 2016 | 4 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2021 | 1 |
| 2022 | 1 |
| 2023 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K230005 | Pantheris LV Atherectomy Catheter | MCW | Substantially Equivalent | |
| K230594 | Tigereye ST CTO-Crossing Catheter | PDU | Substantially Equivalent | |
| K212468 | Tigereye CTO-Crossing Catheter | PDU | Substantially Equivalent | |
| K212047 | Pantheris System | MCW | Substantially Equivalent | |
| K201330 | Tigereye CTO-Crossing Catheter | PDU | Substantially Equivalent | |
| K182341 | Pantheris SV | MCW | Substantially Equivalent | |
| K173862 | Pantheris System | MCW | Substantially Equivalent | |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | MCW | Substantially Equivalent | |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | MCW | Substantially Equivalent | |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | MCW | Substantially Equivalent | |
| K160827 | Pantheris Catheter | MCW | Substantially Equivalent | |
| K153460 | Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) | MCW | Substantially Equivalent | |
| K152275 | Pantheris System | MCW | Substantially Equivalent | |
| K140185 | OCELOT CATHETER, OCELOT PIXL CATHETER, LIGHTBOX CONSOLE | PDU | Substantially Equivalent | |
| K123532 | OCELOT PIXL CATHETER | PDU | Substantially Equivalent | |
| K123462 | OCELOT CATHETER | PDU | Substantially Equivalent | |
| K122380 | OCELOT SYSTEM | PDU | Substantially Equivalent | |
| K120273 | KITTYCAT CATHETER, KITTYCAT 2 CATHETER | PDU | Substantially Equivalent | |
| K113838 | WILDCAT CATHETER | PDU | Substantially Equivalent | |
| K112579 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER | DQY | Substantially Equivalent | |
| K111704 | AVINGER WILDCAT 6F GUIDEWIRE SUPPORT CATHETER AND JUICEBOX | DQY | Substantially Equivalent | |
| K111338 | WILDCAT CATHETER | PDU | Substantially Equivalent | |
| K102022 | WILDCAT 6F GUIDEWIRE SUPPORT CATHETER MODEL W400L AND W400S | DQY | Substantially Equivalent | |
| K101647 | WILDCAT 5F GUIDEWIRE SUPPORT CATHETER, MODE W500 | DQY | Substantially Equivalent | |
| K083313 | WILDCAT 7F GUIDEWIRE SUPPORT CATHETER | DQY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain