FDA 510(k)

Alivio Ventricular Catheter and Flusher System (Alivio System)

Número K: K172006 · 2017-11-09

Data da decisão2017-11-09

Código do produtoJXG

Comité consultivoNE

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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