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FDA 510(k)

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device

K-Number: K212908 · 2021-10-13

ApplicantNeuravi, Ltd.
Decision Date2021-10-13
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device is a medical device manufactured by Neuravi, Ltd.. It received FDA 510(k) clearance on 2021-10-13 under approval number K212908. 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 II Revascularization Device, EMBOTRAP III Revascularization Device?

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device is a medical device that received FDA 510(k) clearance on 2021-10-13. It is manufactured by Neuravi, Ltd.. The 510(k) number is K212908.

When was EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device approved by the FDA?

EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device received FDA 510(k) clearance on 2021-10-13, under approval number K212908.

What company makes EmboTrap II Revascularization Device, EMBOTRAP III Revascularization Device?

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

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

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

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Other Devices by Neuravi, Ltd.

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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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