FDA 510(k)

CentriMag Acute Circulatory Support System

Номер K: K191557 · 2019-07-10

ЗаявительThoratec Corporation (Now Part of Abbott)

Дата решения2019-07-10

Код продуктаDWA

Консультативный комитетCV

РешениеSubstantially Equivalent

Описание устройства

CentriMag Acute Circulatory Support System is the device name listed in this FDA 510(k) record. The listed applicant is Thoratec Corporation (Now Part of Abbott). It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K191557. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the CentriMag Acute Circulatory Support System?

CentriMag Acute Circulatory Support System is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is Thoratec Corporation (Now Part of Abbott). The 510(k) number is K191557.

When did CentriMag Acute Circulatory Support System receive FDA 510(k) clearance?

CentriMag Acute Circulatory Support System received FDA 510(k) clearance on 2019-07-10, under 510(k) number K191557.

Who is the listed applicant for CentriMag Acute Circulatory Support System?

The FDA 510(k) record lists Thoratec Corporation (Now Part of Abbott) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CentriMag Acute Circulatory Support System?

The FDA product code for CentriMag Acute Circulatory Support System is DWA.

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: DWA)

K232788INSPIRA ART100Inspira Technologies Oxy B.H.N. , Ltd.K230698Консоль насоса Anivia SG1000 Pump ConsoleApmtd, Inc.K221491Консоль насоса Anivia SG1000 Pump ConsoleApmtd, Inc.K192838Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureSpectrum Medical , Ltd.K200306CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag Drainage (Venous) Cannula KitAbbott (Formerly Thoratec Corporation)

Официальный источник

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