FDA 510(k)

量子灌流離心血泵 CP22NG 配合整合感測器（CP22V-NG）

K 號：K250326 · 2025-06-24

決定日期2025-06-24

產品代碼KFM

諮詢委員會履歷

決定相當於

器材摘要

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical S.R.L.. It received FDA 510(k) clearance on 2025-06-24 under 510(k) number K250326. 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 Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is a medical device that received FDA 510(k) clearance on 2025-06-24. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K250326.

When did Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) receive FDA 510(k) clearance?

Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) received FDA 510(k) clearance on 2025-06-24, under 510(k) number K250326.

Who is the listed applicant for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

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

What is the FDA product code for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG)?

The FDA product code for Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors (CP22V-NG) is KFM.

其他以 Spectrum Medical S.R.L. 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：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。

K251762量子灌流離心血泵 CP20NG 配合整合感測器（CP20V-NG）Spectrum Medical S.R.L.K233091量子濾選式血泵CP37搭配整合感測器（CP37V-VT）；量子濾選式血泵CP22搭配整合感測器（CP22V-VT）Qura S.R.L K232132生命星系系統Cardiacassist, Inc.K220842量子濾血離心血泵CP22配內置感測器，量子濾血離心血泵CP20配內置感測器Qura S.R.L K200091Capiox iCP 超速離心泵Terumo Cardiovascular Systems Corporation K201320量子純流心臟血泵 CP22 內置感測器Qura S.R.L

官方來源

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