# K212468: Tigereye CTO-Crossing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Jan 6, 2022 after 153 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: 12 generations back to K890505 (1989). 51 ancestors in all.
No later device cites it as a predicate yet.
1 of 52 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201330: Tigereye CTO-Crossing Catheter, Avinger, Inc. (2020) Summary page 4.

## Indications for use
The Tigereye 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 Tigereye System is contraindicated for use in the iliac, coronary, cerebral, renal, or carotid vasculature.

Source page: https://510kreport.com/device/K212468
Methodology: https://510kreport.com/methodology