FDA 510(k)

NeVa PV Thrombectomy Device

N.º K: K201085 · 2021-01-15

SolicitanteVesalio

Fecha de decisión2021-01-15

Código de productoQEW

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

NeVa PV Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Vesalio. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K201085. 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 NeVa PV Thrombectomy Device?

NeVa PV Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2021-01-15. The listed applicant is Vesalio. The 510(k) number is K201085.

When did NeVa PV Thrombectomy Device receive FDA 510(k) clearance?

NeVa PV Thrombectomy Device received FDA 510(k) clearance on 2021-01-15, under 510(k) number K201085.

Who is the listed applicant for NeVa PV Thrombectomy Device?

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

What is the FDA product code for NeVa PV Thrombectomy Device?

The FDA product code for NeVa PV Thrombectomy Device is QEW.

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Fuente oficial

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