# K201330: Tigereye CTO-Crossing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Sep 10, 2020 after 114 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). 50 ancestors in all.
3 later devices descend from it; 3 cite it directly.
1 of 54 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123532: Ocelot Pixl Catheter, Avinger, Inc. (2012) Summary page 4.

## Most influential descendants
- K230005: Pantheris LV Atherectomy Catheter (2023), 0 descendants of its own
- K230594: Tigereye ST CTO-Crossing Catheter (2023), 0 descendants of its own
- K212468: Tigereye CTO-Crossing Catheter (2022), 0 descendants of its own

## 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/K201330
Methodology: https://510kreport.com/methodology