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FDA 510(k)

EMBOTRAP III Revascularization Device

K-Number: K251789 · 2025-09-25

ApplicantNeuravi Limited
Decision Date2025-09-25
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EMBOTRAP III Revascularization Device is a medical device manufactured by Neuravi Limited. It received FDA 510(k) clearance on 2025-09-25 under approval number K251789. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMBOTRAP III Revascularization Device?

EMBOTRAP III Revascularization Device is a medical device that received FDA 510(k) clearance on 2025-09-25. It is manufactured by Neuravi Limited. The 510(k) number is K251789.

When was EMBOTRAP III Revascularization Device approved by the FDA?

EMBOTRAP III Revascularization Device received FDA 510(k) clearance on 2025-09-25, under approval number K251789.

What company makes EMBOTRAP III Revascularization Device?

EMBOTRAP III Revascularization Device is manufactured by Neuravi Limited.

What is the FDA product code for EMBOTRAP III Revascularization Device?

The FDA product code for EMBOTRAP III Revascularization Device is NRY.

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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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