FDA 510(k)

Auryon Atherectomy System

Numéro K : K260244 · 2026-04-10

Date de décision2026-04-10

Code produitMCW

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Dispositifs connexes (Code : MCW)

K250723FreedomFlow™ Orbital Circumferential Atherectomy System (H6005/ 4Fr 3-Sphere Configuration)Cardio Flow Inc.,K250385Turbo-Elite Laser Atherectomy CatheterSpectranetics K242757Rotarex 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.,

Source officielle

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