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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 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.

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. 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.

Related Devices (Code: QEY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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