FDA 510(k)

EkoSonic Endovascular Device

N.º K: K211080 · 2021-11-19

Fecha de decisión2021-11-19

Código de productoQEY

Comité asesorCV

DecisiónSubstantially Equivalent

Resumen del dispositivo

EkoSonic Endovascular Device is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2021-11-19 under 510(k) number K211080. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the EkoSonic Endovascular Device?

EkoSonic Endovascular Device is a medical device that received FDA 510(k) clearance on 2021-11-19. The listed applicant is Boston Scientific. The 510(k) number is K211080.

When did EkoSonic Endovascular Device receive FDA 510(k) clearance?

EkoSonic Endovascular Device received FDA 510(k) clearance on 2021-11-19, under 510(k) number K211080.

Who is the listed applicant for EkoSonic Endovascular Device?

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

What is the FDA product code for EkoSonic Endovascular Device?

The FDA product code for EkoSonic Endovascular Device is QEY.

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Fuente oficial

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