FDA 510(k)

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

Número K: K200648 · 2020-08-17

Data da decisão2020-08-17

Código do produtoQEY

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do 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.

Perguntas frequentes

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.

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