# K162326: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Oct 18, 2016 after 60 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K890505 (1989). 68 ancestors in all.
3 later devices descend from it; 1 cites it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160827: Pantheris Catheter, Avinger, Inc. (2016) Summary page 5.
- K152275: Pantheris System, Avinger, Inc. (2015) Summary page 5.
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console, Avinger, Inc. (2014) Summary page 5.

## Most influential descendants
- K172236: Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (2017), 2 descendants of its own
- K173862: Pantheris System (2018), 1 descendant of its own
- K212047: Pantheris System (2021), 0 descendants of its own

## Indications for use
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0mm to 7.0mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures and vessel morphologies. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Source page: https://510kreport.com/device/K162326
Methodology: https://510kreport.com/methodology