# K122380: Ocelot System

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Nov 7, 2012 after 93 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: 9 generations back to K890505 (1989). 48 ancestors in all.
14 later devices descend from it; 3 cite it directly.
1 of 63 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111338: Wildcat Catheter, Avinger, Inc. (2011) Summary page 1.
- K050916: Safe-Cross Radio Frequency Total Occlusion Crossing System [Peripheral], Intra Luminal Therapeutics, Inc. (2005) Summary page 1.

## Most influential descendants
- K123532: Ocelot Pixl Catheter (2012), 12 descendants of its own
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console (2014), 7 descendants of its own
- 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

## 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 as an adjunct to fluoroscopy. The Ocelot System is contraindicated for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Source page: https://510kreport.com/device/K122380
Methodology: https://510kreport.com/methodology