FDA 510(k)

量子純流標準熱交換器中流量 1/4 W

K 號：K252541 · 2026-03-12

決定日期2026-03-12

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 Medium Flow 1/4 W 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 2026-03-12 under 510(k) number K252541. 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 Medium Flow 1/4 W?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is a medical device that received FDA 510(k) clearance on 2026-03-12. The listed applicant is Spectrum Medical S.R.L.. The 510(k) number is K252541.

When did Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W receive FDA 510(k) clearance?

Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W received FDA 510(k) clearance on 2026-03-12, under 510(k) number K252541.

Who is the listed applicant for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

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 PureFlow Standard Heat Exchanger Medium Flow 1/4 W?

The FDA product code for Quantum PureFlow Standard Heat Exchanger Medium Flow 1/4 W is DTR.

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。

K240934量子灌流血氧器 ECC VT160-E3 (VT160-E3)；量子灌流血氧器 ECC VT200-E3 (VT200-E3)；量子灌流血氧器 VT75-E3 (VT75-E3)K251762量子灌流離心血泵 CP20NG 配合整合感測器（CP20V-NG）K250326量子灌流離心血泵 CP22NG 配合整合感測器（CP22V-NG）K241206量子灌流混合系統 K241248量子灌流雙腔管31F-V1（DL31F-V1）

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。

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.K220110量子純流標準熱交換器和量子純流心臟停跳熱交換器Qura 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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。