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FDA 510(k)

Auryon Atherectomy Catheters

K-Number: K220116 · 2022-09-26

ApplicantEximo Medical, Ltd.
Decision Date2022-09-26
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Auryon Atherectomy Catheters is a medical device manufactured by Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2022-09-26 under approval number K220116. 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 Catheters?

Auryon Atherectomy Catheters is a medical device that received FDA 510(k) clearance on 2022-09-26. It is manufactured by Eximo Medical, Ltd.. The 510(k) number is K220116.

When was Auryon Atherectomy Catheters approved by the FDA?

Auryon Atherectomy Catheters received FDA 510(k) clearance on 2022-09-26, under approval number K220116.

What company makes Auryon Atherectomy Catheters?

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

What is the FDA product code for Auryon Atherectomy Catheters?

The FDA product code for Auryon Atherectomy Catheters is MCW.

Related Clinical Trials

NCT04229563 Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery Disease COMPLETED

Other Devices by Eximo Medical, Ltd.

K181642B-Laser Atherectomy System K202835Auryon Atherectomy System 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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