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Auryon Atherectomy System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K260244

by Eximo Medical Ltd

Identifiers

510(k) Number
K260244 FDA 510(k)
FDA Product Code
MCW 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 Auryon Atherectomy System is a peripheral atherectomy catheter designed to remove atherosclerotic plaque from blood vessels. It falls under the category of a catheter, peripheral, atherectomy device, and is intended for use in cardiovascular interventions to treat peripheral artery disease (PAD).

This system is supplied as a sterile, single-use device and is intended for use in clinical settings such as catheterization labs. It is classified as a Class 2 medical device under FDA regulations (870.4875) and has received FDA 510(k) clearance (K260244). The device is available in multiple reference codes (e.g., 3003862657, 1721676) and is intended for femoral, pedal, or radial access procedures. Storage and handling must comply with sterile medical device protocols.

Frequently asked questions

What types of vascular access points is the Auryon Atherectomy System designed to work with, and how does this affect procedure planning?

The Auryon Atherectomy System is specifically designed for use with femoral, pedal, or radial access procedures, meaning it can be deployed through these common entry points for peripheral artery interventions. This versatility allows clinicians to choose the most appropriate access route based on patient anatomy, existing vascular conditions, or procedural preferences, ensuring flexibility in treating peripheral artery disease (PAD) in various locations.

Is the Auryon Atherectomy System intended for reuse, or is it meant to be used only once per patient? How should it be handled to maintain sterility?

The Auryon Atherectomy System is supplied as a sterile, single-use device, meaning it is intended for one-time use per patient. To maintain sterility, it must be handled according to standard sterile medical device protocols—typically involving unsealed packaging until immediately before use, avoiding contamination, and adhering to facility-specific sterile processing guidelines for catheter-based interventions.

What regulatory pathway did the Auryon Atherectomy System follow to gain market authorization, and which advisory committee was involved?

The Auryon Atherectomy System received FDA 510(k) clearance (K260244) through the traditional review pathway, classified as substantially equivalent to a predicate device. The Cardiovascular (CV) Advisory Committee was involved in the review process, as indicated by the product’s classification under OpenFDA’s medical specialty description for cardiovascular devices.

Are there multiple sizes or models available for the Auryon Atherectomy System, and if so, how might this affect patient selection or procedural approach?

While the provided data does not specify exact sizes or models (e.g., catheter diameters, lengths, or plaque-targeting configurations), the system is listed under multiple OpenFDA registration numbers (e.g., 3003862657, 1721676), suggesting variability in available options. Clinicians should consult the manufacturer’s documentation or catalog for precise sizing details, as these may influence selection based on lesion type, vessel diameter, or access route (e.g., smaller profiles for radial access vs. larger for femoral).

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: The Auryon Atherectomy System | AngioDynamics, Technology | The Auryon System for PAD, Auryon Atherectomy System - Eximo Medical | FDA Evidence Review, Auryon Atherectomy System - Eximo Medical | FDA Evidence Review

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eximo Medical Ltd
FDA Applicant
Eximo Medical

Sources (1)

  • FDA 510(k) K260244 24 fields · synced Sep 19, 2026