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FDA 510(k)

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

K-Number: K200648 · 2020-08-17

ApplicantEkos Corporation
Decision Date2020-08-17
Product CodeQEY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is a medical device manufactured by Ekos Corporation. It received FDA 510(k) clearance on 2020-08-17 under approval number K200648. The device is classified under product code QEY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Ekos Corporation. The 510(k) number is K200648.

When was EKOS PE Endovascular Device with Control System 4.0 (CS4.0) approved by the FDA?

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

What company makes EKOS PE Endovascular Device with Control System 4.0 (CS4.0)?

EKOS PE Endovascular Device with Control System 4.0 (CS4.0) is manufactured by Ekos Corporation.

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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