FDA 510(k)

EZE SIT 過濾刀

K 號：K190267 · 2019-10-30

決定日期2019-10-30

產品代碼MGZ

諮詢委員會履歷

決定相當於

器材摘要

EZE SIT Valvulotome is the device name listed in this FDA 510(k) record. The listed applicant is Lemaitre Vascular. It received FDA 510(k) clearance on 2019-10-30 under 510(k) number K190267. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the EZE SIT Valvulotome?

EZE SIT Valvulotome is a medical device that received FDA 510(k) clearance on 2019-10-30. The listed applicant is Lemaitre Vascular. The 510(k) number is K190267.

When did EZE SIT Valvulotome receive FDA 510(k) clearance?

EZE SIT Valvulotome received FDA 510(k) clearance on 2019-10-30, under 510(k) number K190267.

Who is the listed applicant for EZE SIT Valvulotome?

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

What is the FDA product code for EZE SIT Valvulotome?

The FDA product code for EZE SIT Valvulotome is MGZ.

其他以 Lemaitre Vascular 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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相關器械（代碼：MGZ）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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