FDA 510(k)

MC3 快流雙腔導管

K 號：K171610 · 2017-11-16

決定日期2017-11-16

產品代碼PZS

諮詢委員會履歷

決定相當於

器材摘要

MC3 QuickFlow Dual Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Mc3 Incorporated. It received FDA 510(k) clearance on 2017-11-16 under 510(k) number K171610. 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 QuickFlow Dual Lumen Catheter?

MC3 QuickFlow Dual Lumen Catheter is a medical device that received FDA 510(k) clearance on 2017-11-16. The listed applicant is Mc3 Incorporated. The 510(k) number is K171610.

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

MC3 QuickFlow Dual Lumen Catheter received FDA 510(k) clearance on 2017-11-16, under 510(k) number K171610.

Who is the listed applicant for MC3 QuickFlow Dual Lumen Catheter?

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

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

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

其他以 Mc3 Incorporated 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。

K191935海龍智能 ECMO 模組 K182914MC3 靜脈通路套件 21030 K180151MC3 頸內雙腔導管

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。

K232480ProtekDuo 靜脈-靜脈針管組Cardiacassist, Inc.K203409MC3新月形雙腔靜脈內針管Mc3, Inc.K180151MC3 頸內雙腔導管Mc3 Incorporated

官方來源

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