Avinger, Inc.: FDA filings under this applicant name
FDA lists 25 510(k) clearances under the applicant name “Avinger, Inc.” (first 2009, latest 2023), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 84 days. Since 2017 the median was 146 days, against 104 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 5 | 60 |
| 2013 | 0 | — |
| 2014 | 1 | 97 |
| 2015 | 1 | 63 |
| 2016 | 4 | 45 |
| 2017 | 1 | 97 |
| 2018 | 1 | 153 |
| 2019 | 1 | 224 |
| 2020 | 1 | 114 |
| 2021 | 1 | 139 |
| 2022 | 1 | 153 |
| 2023 | 2 | 104 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Avinger, Inc. took a median 146 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 104 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MCW | Catheter, Peripheral, Atherectomy | 10 | 10 |
| PDU | Catheter For Crossing Total Occlusions | 10 | 10 |
| DQY | Catheter, Percutaneous | 5 | 5 |
Review panels
- Cardiovascular (25)
Most recent Avinger, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230005 | Pantheris LV Atherectomy Catheter | MCW | 2023-06-06 | 154 |
| K230594 | Tigereye ST CTO-Crossing Catheter | PDU | 2023-04-25 | 53 |
| K212468 | Tigereye CTO-Crossing Catheter | PDU | 2022-01-06 | 153 |
| K212047 | Pantheris System | MCW | 2021-11-16 | 139 |
| K201330 | Tigereye CTO-Crossing Catheter | PDU | 2020-09-10 | 114 |
| K182341 | Pantheris SV | MCW | 2019-04-09 | 224 |
| K173862 | Pantheris System | MCW | 2018-05-22 | 153 |
| K172236 | Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled | MCW | 2017-10-30 | 97 |
| K163264 | Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled | MCW | 2016-12-21 | 30 |
| K162326 | Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled | MCW | 2016-10-18 | 60 |
15 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Avinger, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Avinger, Inc. is the lead sponsor of 6 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT04793581: Assessment of the Utility of the Pantheris Small Vessel (SV) System (Recruiting, started 2021-01-29)
- NCT03480685: Evaluation of Imaging of Peripheral Arteries by Optical Coherence Tomography and Intravascular Ultrasound Imaging (Completed, started 2018-05-24)
- NCT03192696: Pantheris Atherectomy Treatment of In-Stent Restenosis In Lower Extremity Arteries (Completed, started 2017-10-19)
- NCT01937351: Evaluation of the Pantheris Atherectomy System (Completed, started 2013-06-25)
- NCT01537302: Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II (Completed, started 2012-02)
Frequently asked questions
How many FDA 510(k) clearances are listed under Avinger, Inc.?
FDA lists 25 510(k) clearances under the applicant name “Avinger, Inc.” (first 2009, latest 2023), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Avinger, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Avinger, Inc. is 84 days. Since 2017: 146 days, versus 104 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Avinger, Inc.?
The most frequent FDA product codes under this applicant name are MCW (Catheter, Peripheral, Atherectomy, 10); PDU (Catheter For Crossing Total Occlusions, 10); DQY (Catheter, Percutaneous, 5).
Next steps
- See all 25 Avinger, Inc. clearances with predicates and recalls
- Run predicate analysis for product code MCW, Avinger, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.