FDA 510(k)

TandemHeart 泵及護理控制器

K 號：K202751 · 2021-03-26

決定日期2021-03-26

產品代碼QNR

諮詢委員會履歷

決定相當於

器材摘要

TandemHeart Pump and Escort Controller is the device name listed in this FDA 510(k) record. The listed applicant is Cardiacassist, Inc.. It received FDA 510(k) clearance on 2021-03-26 under 510(k) number K202751. The device is classified under product code QNR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the TandemHeart Pump and Escort Controller?

TandemHeart Pump and Escort Controller is a medical device that received FDA 510(k) clearance on 2021-03-26. The listed applicant is Cardiacassist, Inc.. The 510(k) number is K202751.

When did TandemHeart Pump and Escort Controller receive FDA 510(k) clearance?

TandemHeart Pump and Escort Controller received FDA 510(k) clearance on 2021-03-26, under 510(k) number K202751.

Who is the listed applicant for TandemHeart Pump and Escort Controller?

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

What is the FDA product code for TandemHeart Pump and Escort Controller?

The FDA product code for TandemHeart Pump and Escort Controller is QNR.

其他以 Cardiacassist, Inc. 為申請人之記錄

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相關器械（代碼：QNR）

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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