FDA 510(k)

Auryon Atherectomy Catheters

Número K: K220116 · 2022-09-26

Data da decisão2022-09-26

Código do produtoMCW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Auryon Atherectomy Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Eximo Medical, Ltd.. It received FDA 510(k) clearance on 2022-09-26 under 510(k) number K220116. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Auryon Atherectomy Catheters?

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

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

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

Who is the listed applicant for Auryon Atherectomy Catheters?

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

What is the FDA product code for Auryon Atherectomy Catheters?

The FDA product code for Auryon Atherectomy Catheters is MCW.

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Outros registros que listam Eximo Medical, Ltd. como candidato(a)

K241553Auryon Atherectomy Catheter 1.7mm; Auryon Atherectomy Catheter 1.7mm, Hydrophilic Coating 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 K221077Auryon Atherectomy System K202835Auryon Atherectomy System K181642B-Laser Atherectomy System

Ver todos os 7 dispositivos →

Dispositivos Relacionados (Código: MCW)

K260244Auryon Atherectomy SystemEximo Medical 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.

Fonte oficial

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