FDA 510(k)

EV1000 Clinical Platform NI, EV1000 Clinical Platform

K-Number: K192058 · 2019-08-30

Decision Date2019-08-30

Product CodeDXN

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EV1000 Clinical Platform NI, EV1000 Clinical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2019-08-30 under 510(k) number K192058. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EV1000 Clinical Platform NI, EV1000 Clinical Platform?

EV1000 Clinical Platform NI, EV1000 Clinical Platform is a medical device that received FDA 510(k) clearance on 2019-08-30. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K192058.

When did EV1000 Clinical Platform NI, EV1000 Clinical Platform receive FDA 510(k) clearance?

EV1000 Clinical Platform NI, EV1000 Clinical Platform received FDA 510(k) clearance on 2019-08-30, under 510(k) number K192058.

Who is the listed applicant for EV1000 Clinical Platform NI, EV1000 Clinical Platform?

The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EV1000 Clinical Platform NI, EV1000 Clinical Platform?

The FDA product code for EV1000 Clinical Platform NI, EV1000 Clinical Platform is DXN.

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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.