FDA 510(k)

Solus Gold Embolization Device

Número K: K213200 · 2022-03-21

Data da decisão2022-03-21

Código do produtoKRD

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Solus Gold Embolization Device is the device name listed in this FDA 510(k) record. The listed applicant is Artio Medical, Inc.. It received FDA 510(k) clearance on 2022-03-21 under 510(k) number K213200. The device is classified under product code KRD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Solus Gold Embolization Device?

Solus Gold Embolization Device is a medical device that received FDA 510(k) clearance on 2022-03-21. The listed applicant is Artio Medical, Inc.. The 510(k) number is K213200.

When did Solus Gold Embolization Device receive FDA 510(k) clearance?

Solus Gold Embolization Device received FDA 510(k) clearance on 2022-03-21, under 510(k) number K213200.

Who is the listed applicant for Solus Gold Embolization Device?

The FDA 510(k) record lists Artio Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Solus Gold Embolization Device?

The FDA product code for Solus Gold Embolization Device is KRD.

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