# K212047: Pantheris System

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Nov 16, 2021 after 139 days
- Product code: MCW (Catheter, Peripheral, Atherectomy)
- Device class: 2
- Regulation: 21 CFR 870.4875
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K890505 (1989). 91 ancestors in all.
No later device cites it as a predicate yet.
1 of 92 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181642: B-Laser Atherectomy System, Eximo Medical, Ltd. (2018) Summary page 4.
- K173862: Pantheris System, Avinger, Inc. (2018) Summary page 5.

## Indications for use
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded native or restenotic vessels, including in-stent restenosis (ISR), in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation and imaging. The system is an adjunct to fluoroscopy by providing images of vessel lumen, wall structures, and vessel morphologies. The Pantheris System is not intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Source page: https://510kreport.com/device/K212047
Methodology: https://510kreport.com/methodology