FDA 510(k)

Alivio Ventricular Catheter and Flusher System (Alivio System)

Номер K: K172006 · 2017-11-09

Дата решения2017-11-09

Код продуктаJXG

Консультативный комитетNE

РешениеSubstantially Equivalent

Описание устройства

Alivio Ventricular Catheter and Flusher System (Alivio System) is the device name listed in this FDA 510(k) record. The listed applicant is Alcyone Lifesciences, Inc.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K172006. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Часто задаваемые вопросы

What is the Alivio Ventricular Catheter and Flusher System (Alivio System)?

Alivio Ventricular Catheter and Flusher System (Alivio System) is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Alcyone Lifesciences, Inc.. The 510(k) number is K172006.

When did Alivio Ventricular Catheter and Flusher System (Alivio System) receive FDA 510(k) clearance?

Alivio Ventricular Catheter and Flusher System (Alivio System) received FDA 510(k) clearance on 2017-11-09, under 510(k) number K172006.

Who is the listed applicant for Alivio Ventricular Catheter and Flusher System (Alivio System)?

The FDA 510(k) record lists Alcyone Lifesciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alivio Ventricular Catheter and Flusher System (Alivio System)?

The FDA product code for Alivio Ventricular Catheter and Flusher System (Alivio System) is JXG.

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: JXG)

K261004Codman® Distal Peritoneal Catheter, Barium Open End (82-1682); Codman® HOLTER® Peritoneal Catheter (SALMON Design) (82-1684)Integra Lifesciences Production Corporation K251598IntellidropBrainspace, Inc.K250636Sophy Mini Monopressure Valve (SM1)Sophysa K252514EVAC-MRIPhasor Health, LLC K243531Codman Libertís Shunt Catheter with Bactiseal and Endexo TechnologyIntegra Lifesciences Production Corporation K243552Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821761); Codman Libertís™ 1.9 mm EVD Catheter with Bactiseal® and Endexo® Technology with Luer Connection (821762)Integra Lifesciences Production Corporation

Официальный источник

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