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FDA 510(k)

Auryon Atherectomy System

K-Number: K260244 · 2026-04-10

ApplicantEximo Medical
Decision Date2026-04-10
Product CodeMCW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Auryon Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K260244. 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 2026-04-10. The listed applicant is Eximo Medical. The 510(k) number is K260244.

When did Auryon Atherectomy System receive FDA 510(k) clearance?

Auryon Atherectomy System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K260244.

Who is the listed applicant for Auryon Atherectomy System?

The FDA 510(k) record lists Eximo Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Auryon Atherectomy System?

The FDA product code for Auryon Atherectomy System is MCW.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT04229563Post-Market Registry of AURYON Atherectomy Device in Subjects Affected With Infrainguinal Peripheral Artery DiseaseCOMPLETED

Other records listing Eximo Medical as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingK233668Auryon 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 SystemK220116Auryon Atherectomy CathetersK221077Auryon Atherectomy SystemK202835Auryon Atherectomy System

View all 8 devices →

Related Devices (Code: MCW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectraneticsK242757Rotarex Atherectomy SystemBard Peripheral Vascular, Inc.K242947FreedomFlow™ Orbital Circumferential Atherectomy SystemCardio Flow Inc.,K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic CoatingEximo Medical, Ltd.K233483FreedomFlow Orbital Circumferential Atherectomy System (H6004/5Fr 3-Sphere Configuration)Cardio Flow 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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