FDA 510(k)

Akura Thrombectomy System

N.º K: K251070 · 2025-11-25

Fecha de decisión2025-11-25

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Akura Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Akura Medical. It received FDA 510(k) clearance on 2025-11-25 under 510(k) number K251070. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Akura Thrombectomy System?

Akura Thrombectomy System is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is Akura Medical. The 510(k) number is K251070.

When did Akura Thrombectomy System receive FDA 510(k) clearance?

Akura Thrombectomy System received FDA 510(k) clearance on 2025-11-25, under 510(k) number K251070.

Who is the listed applicant for Akura Thrombectomy System?

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

What is the FDA product code for Akura Thrombectomy System?

The FDA product code for Akura Thrombectomy System is QEW.

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Fuente oficial

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