FDA 510(k)

MC3新月形雙腔靜脈內針管

K 號：K203409 · 2021-05-03

決定日期2021-05-03

產品代碼PZS

諮詢委員會履歷

決定相當於

器材摘要

MC3 Crescent Jugular Dual Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mc3, Inc.. It received FDA 510(k) clearance on 2021-05-03 under 510(k) number K203409. The device is classified under product code PZS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the MC3 Crescent Jugular Dual Lumen Catheter?

MC3 Crescent Jugular Dual Lumen Catheter is a medical device that received FDA 510(k) clearance on 2021-05-03. The listed applicant is Mc3, Inc.. The 510(k) number is K203409.

When did MC3 Crescent Jugular Dual Lumen Catheter receive FDA 510(k) clearance?

MC3 Crescent Jugular Dual Lumen Catheter received FDA 510(k) clearance on 2021-05-03, under 510(k) number K203409.

Who is the listed applicant for MC3 Crescent Jugular Dual Lumen Catheter?

The FDA 510(k) record lists Mc3, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MC3 Crescent Jugular Dual Lumen Catheter?

The FDA product code for MC3 Crescent Jugular Dual Lumen Catheter is PZS.

其他以 Mc3, Inc. 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：PZS）

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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