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FDA 510(k)

Artix BG

K-Number: K230912 · 2023-05-02

ApplicantInari Medical
Decision Date2023-05-02
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Artix BG is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2023-05-02 under approval number K230912. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artix BG?

Artix BG is a medical device that received FDA 510(k) clearance on 2023-05-02. It is manufactured by Inari Medical. The 510(k) number is K230912.

When was Artix BG approved by the FDA?

Artix BG received FDA 510(k) clearance on 2023-05-02, under approval number K230912.

What company makes Artix BG?

Artix BG is manufactured by Inari Medical.

What is the FDA product code for Artix BG?

The FDA product code for Artix BG is QEW.

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Related Devices (Code: QEW)

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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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