FDA 510(k)

NaviCross 0.018

K 號：K173799 · 2018-03-29

決定日期2018-03-29

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

NaviCross 0.018 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Corporation. It received FDA 510(k) clearance on 2018-03-29 under 510(k) number K173799. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NaviCross 0.018?

NaviCross 0.018 is a medical device that received FDA 510(k) clearance on 2018-03-29. The listed applicant is Terumo Corporation. The 510(k) number is K173799.

When did NaviCross 0.018 receive FDA 510(k) clearance?

NaviCross 0.018 received FDA 510(k) clearance on 2018-03-29, under 510(k) number K173799.

Who is the listed applicant for NaviCross 0.018?

The FDA 510(k) record lists Terumo Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NaviCross 0.018?

The FDA product code for NaviCross 0.018 is DQY.

其他以 Terumo Corporation 為申請人之記錄

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