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Pantheris Catheter (8F); Pantheris Catheter (7F); Lightbox HS Imaging Console; Lightbox Sled

FDA 510(k)

Class II (US FDA 510(k))

510(k) K163264

by Avinger, Inc.

Identifiers

510(k) Number
K163264 FDA 510(k)
FDA Product Code
MCW FDA 510(k)
Models / Variants
Pantheris Catheter (8F) FDA 510(k)
Pantheris Cather (7F) FDA 510(k)
Lightbox HS Imaging Console FDA 510(k)
Lightbox Sled FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4875 FDA 510(k)
Regulation Number
870.4875 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Pantheris System is a directional atherectomy device for peripheral vasculature that combines optical coherence tomography (OCT) imaging with atherectomy capabilities. System components include the Pantheris Catheter (available in 7F and 8F sizes), Lightbox Sled with integrated Umbilical, and the Lightbox HS Imaging Console.

The device is supplied as part of the Pantheris System and is intended for use in peripheral vascular procedures. It has received FDA 510(k) clearance with a device class of 2 and product code MCW. The system includes catheters in 7F and 8F sizes and is designed for use with the Lightbox HS Imaging Console and Lightbox Sled components.

Frequently asked questions

What is the Pantheris System used for?

The Pantheris System is a directional atherectomy device for peripheral vasculature that combines optical coherence tomography (OCT) imaging with atherectomy capabilities, designed for use in peripheral vascular procedures.

What components are included in the Pantheris System?

The system includes the Pantheris Catheter (available in 7F and 8F sizes), Lightbox Sled with integrated Umbilical, and the Lightbox HS Imaging Console, all supplied as part of the complete system.

Is the Pantheris Catheter single-use or reusable?

The device data does not specify whether the Pantheris Catheter is single-use or reusable. This information would need to be confirmed with the manufacturer or product instructions for use.

What regulatory approvals has the Pantheris System received?

The Pantheris System has received FDA 510(k) clearance with a device class of 2 and product code MCW, classified as substantially equivalent to predicate devices for peripheral vascular atherectomy procedures.

What sizes are available for the Pantheris Catheter?

The Pantheris Catheter is available in two sizes: 7F and 8F, allowing for flexibility in treating different peripheral vascular anatomies and clinical scenarios.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging ..., Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging ..., Pantheris Catheter (8F), Pantheris Catheter (7F), Lightbox HS Imaging ..., Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Avinger, Inc.

Sources (1)

  • FDA 510(k) K163264 24 fields · synced Sep 28, 2026