Identifiers
- 510(k) Number
- K202835 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 catheter, peripheral, atherectomy device. It is classified as a Class 2 medical device. The system is designed for atherectomy procedures.
The Auryon Atherectomy System is supplied as a single device and is intended for use in cardiovascular procedures. It has been cleared by the FDA via the 510(k) pathway and is manufactured by Eximo Medical Ltd. The device is used for treating lesions, including those above and below the knee, through femoral, pedal, or radial access.
Frequently asked questions
What is the Auryon Atherectomy System used for?
The Auryon Atherectomy System is used for treating lesions, including those above and below the knee, through femoral, pedal, or radial access, in cardiovascular procedures.
Is the Auryon Atherectomy System supplied as a single device?
Yes, the Auryon Atherectomy System is supplied as a single device, intended for use in atherectomy procedures.
What is the regulatory status of the Auryon Atherectomy System?
The Auryon Atherectomy System has been cleared by the FDA via the 510(k) pathway, classified as a Class 2 medical device.
What type of access can be used with the Auryon Atherectomy System?
The Auryon Atherectomy System can be used through femoral, pedal, or radial access for treating lesions.
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
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K202835 | Class II | Active |
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Manufacturer
- Manufacturer
- Eximo Medical Ltd
- FDA Applicant
- Eximo Medical, Ltd.
Sources (1)
- FDA 510(k) K202835 24 fields · synced Sep 22, 2026