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FDA 510(k)

DEEPVESSEL Plaque

K-Number: K260497 · 2026-06-04

ApplicantKeya Medical Technology Co., Ltd.
Decision Date2026-06-04
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEEPVESSEL Plaque is the device name listed in this FDA 510(k) record. The listed applicant is Keya Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-06-04 under 510(k) number K260497. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DEEPVESSEL Plaque?

DEEPVESSEL Plaque is a medical device that received FDA 510(k) clearance on 2026-06-04. The listed applicant is Keya Medical Technology Co., Ltd.. The 510(k) number is K260497.

When did DEEPVESSEL Plaque receive FDA 510(k) clearance?

DEEPVESSEL Plaque received FDA 510(k) clearance on 2026-06-04, under 510(k) number K260497.

Who is the listed applicant for DEEPVESSEL Plaque?

The FDA 510(k) record lists Keya Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEEPVESSEL Plaque?

The FDA product code for DEEPVESSEL Plaque is QIH.

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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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