FDA 510(k)

量子純流標準熱交換器和量子純流心臟停跳熱交換器

K 號：K220110 · 2022-05-06

決定日期2022-05-06

產品代碼DTR

諮詢委員會履歷

決定相當於

器材摘要

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger 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 2022-05-06 under 510(k) number K220110. The device is classified under product code DTR. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger?

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Qura S.R.L. The 510(k) number is K220110.

When did Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger receive FDA 510(k) clearance?

Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger received FDA 510(k) clearance on 2022-05-06, under 510(k) number K220110.

Who is the listed applicant for Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger?

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 Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger?

The FDA product code for Quantum PureFlow Standard Heat Exchanger and Quantum PureFlow Cardioplegia Heat Exchanger is DTR.

其他以 Qura S.R.L 為申請人之記錄

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相關器械（代碼：DTR）

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。

K252541量子純流標準熱交換器中流量 1/4 WSpectrum Medical S.R.L.K240908量子微心臟停跳輸送系統；量子微心臟停跳輸送模組（QMCDM）Spectrum Medical , Ltd.K250150VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合帶分流）；VANGUARD 血液心肺機系統（Vanguard 4:1 血液心肺機組合迷你版）Sorin Group Italia S.R.L.K240190MYOtherm XP 心肌停搏液輸送系統搭配 Cortiva 生物活性表面，MYOtherm XP 心肌停搏液輸送系統未包裝Medtronic K223879量子純流標準熱交換器（HX11W-S2、HX11W-S1M及HX11W-S2M）Quara S.R.L.K212688量子純流標準熱交換器，量子純流心臟停跳熱交換器Qura S.R.L

官方來源

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