FDA 510(k)

Solus Gold Embolization Device

Номер K: K213200 · 2022-03-21

Дата решения2022-03-21

Код продуктаKRD

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: KRD)

K252812UniPearls® Embolic MicrospheresSuzhou Haowei Medical Technology Co., Ltd.K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation K261866Concerto Versa™ Detachable CoilMedtronic, Inc.K260635HARBOR Occlusion DeviceNuvascular, Inc.K260508LOBO Vascular Occlusion SystemOkami Medical, Inc.K253511Concerto Versa™ Detachable CoilMedtronic, Inc.

Официальный источник

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