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FDA 510(k)

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform

K-Number: K203131 · 2021-01-22

ApplicantEdwards Lifesciences, LLC
Decision Date2021-01-22
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2021-01-22 under approval number K203131. 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 Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform?

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform is a medical device that received FDA 510(k) clearance on 2021-01-22. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K203131.

When was EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform approved by the FDA?

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform received FDA 510(k) clearance on 2021-01-22, under approval number K203131.

What company makes EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform?

EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform?

The FDA product code for EV1000 Clinical Platform Non-Invasive (NI) or ClearSight System, EV1000 Clinical Platform is DXN.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42173476 Feasibility of applying the Orthopaedic Data Evaluation Panel (ODEP) shoulder criteria for implants used in a United States-based integrated healthcare system. Journal of shoulder and elbow surgery (2026) PMID: 42043129 Iatrogenic Microplastic Exposure: A Possible and Underrecognized Healthcare-Associated Exposure Framework in Human Medicotoxicological Risk. Toxics (2026)

Other Devices by Edwards Lifesciences, LLC

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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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