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FDA 510(k)

WIRION

K-Number: K180023 · 2018-03-21

ApplicantGardia Medical , Ltd.
Decision Date2018-03-21
Product CodeNTE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WIRION is a medical device manufactured by Gardia Medical , Ltd.. It received FDA 510(k) clearance on 2018-03-21 under approval number K180023. The device is classified under product code NTE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WIRION?

WIRION is a medical device that received FDA 510(k) clearance on 2018-03-21. It is manufactured by Gardia Medical , Ltd.. The 510(k) number is K180023.

When was WIRION approved by the FDA?

WIRION received FDA 510(k) clearance on 2018-03-21, under approval number K180023.

What company makes WIRION?

WIRION is manufactured by Gardia Medical , Ltd..

What is the FDA product code for WIRION?

The FDA product code for WIRION is NTE.

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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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