# K152275: Pantheris System

- Pathway: 510(k) (Traditional)
- Applicant: Avinger, Inc.
- Decided: Oct 14, 2015 after 63 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: 12 generations back to K890505 (1989). 65 ancestors in all.
6 later devices descend from it; 2 cite it directly.
1 of 72 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061188: Silverhawk Peripheral Plaque Excision System, Foxhollow Technologies, Inc. (2006) Summary page 5.
- K140185: Ocelot Catheter, Ocelot Pixl Catheter, Lightbox Console, Avinger, Inc. (2014) Summary page 5.

## Most influential descendants
- K153460: Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) (2016), 5 descendants of its own
- K160827: Pantheris Catheter (2016), 4 descendants of its own
- K162326: Pantheris Catheter, Lightbix HS Imaging Console, Lightbox Sled (2016), 3 descendants of its own
- K172236: Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging Console, Lightbox Sled (2017), 2 descendants of its own
- K173862: Pantheris System (2018), 1 descendant of its own

## Indications for use
The Pantheris System is intended to remove plaque (atherectomy) from partially occluded vessels in the peripheral vasculature with a reference diameter of 3.0 mm to 7.0 mm, using OCT-assisted orientation as an adjunct to fluoroscopy. The Pantheris System is NOT intended for use in the iliac, coronary, cerebral, renal or carotid vasculature.

Source page: https://510kreport.com/device/K152275
Methodology: https://510kreport.com/methodology