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FDA 510(k)

Artix Ballon Guiding Sheath

K-Number: K221846 · 2022-07-11

ApplicantInari Medical
Decision Date2022-07-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Artix Ballon Guiding Sheath is a medical device manufactured by Inari Medical. It received FDA 510(k) clearance on 2022-07-11 under approval number K221846. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Artix Ballon Guiding Sheath?

Artix Ballon Guiding Sheath is a medical device that received FDA 510(k) clearance on 2022-07-11. It is manufactured by Inari Medical. The 510(k) number is K221846.

When was Artix Ballon Guiding Sheath approved by the FDA?

Artix Ballon Guiding Sheath received FDA 510(k) clearance on 2022-07-11, under approval number K221846.

What company makes Artix Ballon Guiding Sheath?

Artix Ballon Guiding Sheath is manufactured by Inari Medical.

What is the FDA product code for Artix Ballon Guiding Sheath?

The FDA product code for Artix Ballon Guiding Sheath is DQY.

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Other Devices by Inari Medical

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Related Devices (Code: DQY)

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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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