# K123462: Ocelot Catheter

- Pathway: 510(k) (Special)
- Applicant: Avinger, Inc.
- Decided: Dec 7, 2012 after 28 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: 10 generations back to K890505 (1989). 49 ancestors in all.
No later device cites it as a predicate yet.
1 of 50 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 1.

## 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/K123462
Methodology: https://510kreport.com/methodology