FDA 510(k)

Attain Assist CS Access Catheter

Номер K: K171819 · 2018-01-04

ЗаявительCreganna Medical Also Doing Business AS Ceganna Tactx Medica

Дата решения2018-01-04

Код продуктаDQY

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

Attain Assist CS Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. It received FDA 510(k) clearance on 2018-01-04 under 510(k) number K171819. 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 Attain Assist CS Access Catheter?

Attain Assist CS Access Catheter is a medical device that received FDA 510(k) clearance on 2018-01-04. The listed applicant is Creganna Medical Also Doing Business AS Ceganna Tactx Medica. The 510(k) number is K171819.

When did Attain Assist CS Access Catheter receive FDA 510(k) clearance?

Attain Assist CS Access Catheter received FDA 510(k) clearance on 2018-01-04, under 510(k) number K171819.

Who is the listed applicant for Attain Assist CS Access Catheter?

The FDA 510(k) record lists Creganna Medical Also Doing Business AS Ceganna Tactx Medica as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Attain Assist CS Access Catheter?

The FDA product code for Attain Assist CS Access Catheter 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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