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FDA 510(k)

ArteVu

K-Number: K244007 · 2025-07-30

ApplicantCardio Ring Technologies, Inc. Taiwan Branch
Decision Date2025-07-30
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ArteVu is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Ring Technologies, Inc. Taiwan Branch. It received FDA 510(k) clearance on 2025-07-30 under 510(k) number K244007. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ArteVu?

ArteVu is a medical device that received FDA 510(k) clearance on 2025-07-30. The listed applicant is Cardio Ring Technologies, Inc. Taiwan Branch. The 510(k) number is K244007.

When did ArteVu receive FDA 510(k) clearance?

ArteVu received FDA 510(k) clearance on 2025-07-30, under 510(k) number K244007.

Who is the listed applicant for ArteVu?

The FDA 510(k) record lists Cardio Ring Technologies, Inc. Taiwan Branch as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ArteVu?

The FDA product code for ArteVu is DXN.

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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