FDA 510(k)

EMBA Hourglass Peripheral Embolization Device (PED)

Номер K: K200083 · 2020-02-14

Дата решения2020-02-14

Код продуктаKRD

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

EMBA Hourglass Peripheral Embolization Device (PED) is the device name listed in this FDA 510(k) record. The listed applicant is Embolic Acceleration, LLC. It received FDA 510(k) clearance on 2020-02-14 under 510(k) number K200083. 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 EMBA Hourglass Peripheral Embolization Device (PED)?

EMBA Hourglass Peripheral Embolization Device (PED) is a medical device that received FDA 510(k) clearance on 2020-02-14. The listed applicant is Embolic Acceleration, LLC. The 510(k) number is K200083.

When did EMBA Hourglass Peripheral Embolization Device (PED) receive FDA 510(k) clearance?

EMBA Hourglass Peripheral Embolization Device (PED) received FDA 510(k) clearance on 2020-02-14, under 510(k) number K200083.

Who is the listed applicant for EMBA Hourglass Peripheral Embolization Device (PED)?

The FDA 510(k) record lists Embolic Acceleration, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EMBA Hourglass Peripheral Embolization Device (PED)?

The FDA product code for EMBA Hourglass Peripheral Embolization Device (PED) 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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