FDA 510(k)

Aspirex Thrombectomy System

N.º K: K220270 · 2022-06-21

Fecha de decisión2022-06-21

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

Aspirex Thrombectomy System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2022-06-21 under 510(k) number K220270. 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 Aspirex Thrombectomy System?

Aspirex Thrombectomy System is a medical device that received FDA 510(k) clearance on 2022-06-21. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K220270.

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

Aspirex Thrombectomy System received FDA 510(k) clearance on 2022-06-21, under 510(k) number K220270.

Who is the listed applicant for Aspirex Thrombectomy System?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aspirex Thrombectomy System?

The FDA product code for Aspirex Thrombectomy System is QEW.

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Fuente oficial

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