HemoSphere 流模組
K 號：K253034 · 2025-10-21
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器材摘要
HemoSphere Stream Module is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-10-21 under 510(k) number K253034. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the HemoSphere Stream Module?
HemoSphere Stream Module is a medical device that received FDA 510(k) clearance on 2025-10-21. The listed applicant is Edwards Lifesciences. The 510(k) number is K253034.
When did HemoSphere Stream Module receive FDA 510(k) clearance?
HemoSphere Stream Module received FDA 510(k) clearance on 2025-10-21, under 510(k) number K253034.
Who is the listed applicant for HemoSphere Stream Module?
The FDA 510(k) record lists Edwards Lifesciences as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HemoSphere Stream Module?
The FDA product code for HemoSphere Stream Module is DQK.
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其他以 Edwards Lifesciences 為申請人之記錄
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K254232ECLIPTIS 左心房顯影囊排除系統 (ECS135)；ECLIPTIS 左心房顯影囊排除系統 (ECS140)；ECLIPTIS 左心房顯影囊排除系統 (ECS145)；ECLIPTIS 左心房顯影囊排除系統 (ECS150)K260105Fogarty 強力夾釘，無把柄夾具，及夾具插片K254279愛德華eSheath+ 引導套組K252533HemoSphere Alta先進監控平台（ALTAALL1；ALTACR1；ALTASR1）K252364愛德華eSheath Optima引導套件K243781HemoSphere 高級監視器 (HEM1)；HemoSphere 技術模組 (HEMTOM10)；HemoSphere 清晰視野模組 (HEMCSM10)；智能壓力控制器 (PC1Q)；Acumen IQ Plus 手腕帶 (AIQCA2)；HemoSphere 壓力纜 (HEMPSC100)；HemoSphere Vita 監視器 (HEMVITA1)；HemoSphere Vita 技術模組 (HEMVTOM1)；HemoSphere VitaWave 模組 (HEMVWM1)；VitaWave Plus 手腕帶 (VWCA2)
相關器械（代碼：DQK）
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。
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。
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