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FDA 510(k)

Alivio 心室导管和清潔系統 (Alivio 系統)

K 號：K172006 · 2017-11-09

申請人Alcyone Lifesciences, Inc.
決定日期2017-11-09
產品代碼JXG
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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.

常見問題

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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