# Avinger, Inc.

- Location (FDA's records): Redwood City, CA
- FDA decisions: 25 (2009–2023): 25 510(k) clearances
- Product codes: PDU (10), MCW (10), DQY (5)
- 510(k) review time since 2016: median 97 days, against 103 for FDA's reviews in the same codes and years (3 of 11 faster)
- Predicates its devices cite: 36 (28 its own); citations of its devices by later devices: 29 (28 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Lumend, Inc.: 1 (https://510kreport.com/company/lumend)
- Flowcardia, Inc.: 1 (https://510kreport.com/company/flowcardia)
- Eximo Medical, Ltd.: 1 (https://510kreport.com/company/eximo-medical)
- Intra Luminal Therapeutics, Inc.: 1 (https://510kreport.com/company/intra-luminal-therapeutics)
- Foxhollow Technologies, Inc.: 1 (https://510kreport.com/company/foxhollow-technologies)
- Lightlab Imaging, Inc.: 1 (https://510kreport.com/company/lightlab-imaging)
- Asahi Intecc Co., Ltd.: 1 (https://510kreport.com/company/asahi-intecc)
- Vascular Solutions, Inc.: 1 (https://510kreport.com/company/vascular-solutions)

## Firms that cite its devices most
- Volcano Corporation: 1 (https://510kreport.com/company/volcano)

## Its most-cited devices
- K111338: Wildcat Catheter (2011), cited by 3
- K201330: Tigereye CTO-Crossing Catheter (2020), cited by 3
- K122380: Ocelot System (2012), cited by 3
- K111704: Avinger Wildcat 6F Guidewire Support Catheter and Juicebox (2011), cited by 2
- K123532: Ocelot Pixl Catheter (2012), cited by 2
- K101647: Wildcat 5F Guidewire Support Catheter, Mode W500 (2010), cited by 2

## Recent decisions
- K230005: Pantheris LV Atherectomy Catheter (Jun 6, 2023)
- K230594: Tigereye ST CTO-Crossing Catheter (Apr 25, 2023)
- K212468: Tigereye CTO-Crossing Catheter (Jan 6, 2022)
- K212047: Pantheris System (Nov 16, 2021)
- K201330: Tigereye CTO-Crossing Catheter (Sep 10, 2020)
- K182341: Pantheris SV (Apr 9, 2019)
- K173862: Pantheris System (May 22, 2018)
- K172236: Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (Oct 30, 2017)

Source page: https://510kreport.com/company/avinger