FDA 510(k)

EMBOTRAP III Revascularization Device

K-Number: K193063 · 2020-07-14

Decision Date2020-07-14

Product CodeNRY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

EMBOTRAP III Revascularization Device is a medical device manufactured by Neuravi, Ltd.. It received FDA 510(k) clearance on 2020-07-14 under approval number K193063. 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 2020-07-14. It is manufactured by Neuravi, Ltd.. The 510(k) number is K193063.

When was EMBOTRAP III Revascularization Device approved by the FDA?

EMBOTRAP III Revascularization Device received FDA 510(k) clearance on 2020-07-14, under approval number K193063.

What company makes EMBOTRAP III Revascularization Device?

EMBOTRAP III Revascularization Device is manufactured by Neuravi, Ltd..

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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Other Devices by Neuravi, Ltd.

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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.