# K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: May 1, 2014 after 97 days
- Product code: PDU (Catheter For Crossing Total Occlusions)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 11 generations back to K890505 (1989). 56 ancestors in all.
7 later devices descend from it; 2 cite it directly.
1 of 64 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122380: Ocelot System, Avinger, Inc. (2012) Summary page 2.
- K123532: Ocelot Pixl Catheter, Avinger, Inc. (2012) Summary page 2.
- K093857: C7 XR Imaging System with C7 Dragonfly Imaging Catheter and Disposable Accessories, Lightlab Imaging, Inc. (2010) Summary page 2.

## Most influential descendants
- K152275: Pantheris System (2015), 6 descendants of its own
- K153460: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (2016), 5 descendants of its own
- K160827: Pantheris Catheter (2016), 4 descendants of its own
- K162326: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (2016), 3 descendants of its own
- K172236: Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (2017), 2 descendants of its own

## Indications for use
The Ocelot System is intended to facilitate the intraluminal placement of conventional guidewires beyond stenotic lesions (including sub and chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen and wall structures. The Ocelot System is contraindlicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Source page: https://510kreport.com/device/K140185
Methodology: https://510kreport.com/methodology