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FDA 510(k)

Auryon Atherectomy System

K-Number: K202835 · 2020-12-02

ApplicantEximo Medical, Ltd.
Decision Date2020-12-02
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Auryon Atherectomy System is a medical device manufactured by Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2020-12-02 under approval number K202835. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Auryon Atherectomy System?

Auryon Atherectomy System is a medical device that received FDA 510(k) clearance on 2020-12-02. It is manufactured by Eximo Medical, Ltd.. The 510(k) number is K202835.

When was Auryon Atherectomy System approved by the FDA?

Auryon Atherectomy System received FDA 510(k) clearance on 2020-12-02, under approval number K202835.

What company makes Auryon Atherectomy System?

Auryon Atherectomy System is manufactured by Eximo Medical, Ltd..

What is the FDA product code for Auryon Atherectomy System?

The FDA product code for Auryon Atherectomy System is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED NCT07105930 Trial to Assess Non-inferiority of an Orbital Atherectomy Only Versus a Calcium-tailored Debulking Approach RECRUITING

Other Devices by Eximo Medical, Ltd.

K181642B-Laser Atherectomy System K220116Auryon Atherectomy Catheters K221077Auryon Atherectomy System K233668Auryon Atherectomy Catheter 1.5 mm XL, Hydrophilic Coating (EXM-4010-H000), Auryon Atherectomy Catheter 0.9 mm XL, Hydrophilic Coating (EXM-4011-H000), Auryon Atherectomy Catheter 1.5 mm XL (EXM -4010-0000), Auryon Atherectomy Catheter 0.9 mm XL (EXM-4011-0000) K230709Auryon Atherectomy System K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating

View all 7 devices →

Related Devices (Code: MCW)

K163264Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox SledAvinger, Inc. K162326Pantheris Catheter, Lightbix HS Imaging Console, Lightbox SledAvinger, Inc. K161361HawkOne Directional Atherectomy SystemMedtronic Vascular, Inc. K160827Pantheris CatheterAvinger, Inc. K153460Pantheris Catheter (8Fr), Pantheris Catheter (7Fr)Avinger, Inc. K172687Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy CathetersSpectranetics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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