FDA 510(k)

DEEPVESSEL Plaque

Numéro K : K260497 · 2026-06-04

DemandeurKeya Medical Technology Co., Ltd.

Date de décision2026-06-04

Code produitQIH

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Source officielle

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