FDA 510(k)

FineCross M3

K 號：K203521 · 2021-03-03

申請人Ashitaka Factory of Terumo Corporation

決定日期2021-03-03

產品代碼DQY

諮詢委員會履歷

決定相當於

器材摘要

FineCross M3 is the device name listed in this FDA 510(k) record. The listed applicant is Ashitaka Factory of Terumo Corporation. It received FDA 510(k) clearance on 2021-03-03 under 510(k) number K203521. 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 FineCross M3?

FineCross M3 is a medical device that received FDA 510(k) clearance on 2021-03-03. The listed applicant is Ashitaka Factory of Terumo Corporation. The 510(k) number is K203521.

When did FineCross M3 receive FDA 510(k) clearance?

FineCross M3 received FDA 510(k) clearance on 2021-03-03, under 510(k) number K203521.

Who is the listed applicant for FineCross M3?

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

What is the FDA product code for FineCross M3?

The FDA product code for FineCross M3 is DQY.

其他以 Ashitaka Factory of Terumo Corporation 為申請人之記錄

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