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FDA 510(k)

Edwards eSheath Optima introducer set

K-Number: K244046 · 2025-03-27

ApplicantEdwards Lifesciences
Decision Date2025-03-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Edwards eSheath Optima introducer set is a medical device manufactured by Edwards Lifesciences. It received FDA 510(k) clearance on 2025-03-27 under approval number K244046. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Edwards eSheath Optima introducer set?

Edwards eSheath Optima introducer set is a medical device that received FDA 510(k) clearance on 2025-03-27. It is manufactured by Edwards Lifesciences. The 510(k) number is K244046.

When was Edwards eSheath Optima introducer set approved by the FDA?

Edwards eSheath Optima introducer set received FDA 510(k) clearance on 2025-03-27, under approval number K244046.

What company makes Edwards eSheath Optima introducer set?

Edwards eSheath Optima introducer set is manufactured by Edwards Lifesciences.

What is the FDA product code for Edwards eSheath Optima introducer set?

The FDA product code for Edwards eSheath Optima introducer set is DYB.

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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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