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FDA 510(k)

EKOS PE Endovascular Device with Control System 4.0 (CS4.0)

N.º K: K200648 · 2020-08-17

SolicitanteEkos Corporation
Fecha de decisión2020-08-17
Código de productoQEY
Comité asesorCV
DecisiónSubstantially Equivalent

Resumen del dispositivo

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is the device name listed in this FDA 510(k) record. The listed applicant is Ekos Corporation. It received FDA 510(k) clearance on 2020-08-17 under 510(k) number K200648. 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 EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is a medical device that received FDA 510(k) clearance on 2020-08-17. The listed applicant is Ekos Corporation. The 510(k) number is K200648.

When did EKOS PE Endovascular Device with Control System 4.0 (CS4.0) receive FDA 510(k) clearance?

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) received FDA 510(k) clearance on 2020-08-17, under 510(k) number K200648.

Who is the listed applicant for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

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

What is the FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

The FDA product code for EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is QEY.

Ensayos clínicos relacionados

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Dispositivos relacionados (Código: QEY)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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