FDA 510(k)

PG Pro Microcatheter

Номер K: K192625 · 2019-11-21

ЗаявительMicroVention, Inc. A TERUMO Group Company

Дата решения2019-11-21

Код продуктаDQY

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

PG Pro Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc. A TERUMO Group Company. It received FDA 510(k) clearance on 2019-11-21 under 510(k) number K192625. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the PG Pro Microcatheter?

PG Pro Microcatheter is a medical device that received FDA 510(k) clearance on 2019-11-21. The listed applicant is MicroVention, Inc. A TERUMO Group Company. The 510(k) number is K192625.

When did PG Pro Microcatheter receive FDA 510(k) clearance?

PG Pro Microcatheter received FDA 510(k) clearance on 2019-11-21, under 510(k) number K192625.

Who is the listed applicant for PG Pro Microcatheter?

The FDA 510(k) record lists MicroVention, Inc. A TERUMO Group Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PG Pro Microcatheter?

The FDA product code for PG Pro Microcatheter is DQY.

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: DQY)

K262817CrossFAST Integrated Microcatheter Advanced Delivery SystemVantis Vascular, Inc.K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLC K262240SSPC NXT Доставочный катетерCenterPoint Systems, LLC K261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLC K261825Amplatzer TorqVue LP Доставка Система; Amplatzer TorqVue LP КатетерAbbott

Официальный источник

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