FDA 510(k)

量子純流心臟血泵 CP22 內置感測器

K 號：K201320 · 2021-11-03

決定日期2021-11-03

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is the device name listed in this FDA 510(k) record. The listed applicant is Qura S.R.L. It received FDA 510(k) clearance on 2021-11-03 under 510(k) number K201320. The device is classified under product code KFM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is a medical device that received FDA 510(k) clearance on 2021-11-03. The listed applicant is Qura S.R.L. The 510(k) number is K201320.

When did Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor receive FDA 510(k) clearance?

Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor received FDA 510(k) clearance on 2021-11-03, under 510(k) number K201320.

Who is the listed applicant for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

The FDA 510(k) record lists Qura S.R.L as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor?

The FDA product code for Quantum PureFlow Centrifugal Blood Pump CP22 with Integrated Sensor is KFM.

其他以 Qura S.R.L 為申請人之記錄

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相關器械（代碼：KFM）

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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