Artix AX
K-Number: K223436 · 2023-03-02
ApplicantInari Medical
Decision Date2023-03-02
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Artix AX is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2023-03-02 under approval number K223436. 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 AX?
Artix AX is a medical device that received FDA 510(k) clearance on 2023-03-02. It is manufactured by Inari Medical. The 510(k) number is K223436.
When was Artix AX approved by the FDA?
Artix AX received FDA 510(k) clearance on 2023-03-02, under approval number K223436.
What company makes Artix AX?
Artix AX is manufactured by Inari Medical.
What is the FDA product code for Artix AX?
The FDA product code for Artix AX is 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.