FDA 510(k)

HemoSphere Alta先進監控平台（ALTAALL1；ALTACR1；ALTASR1）

K 號：K252533 · 2025-12-18

決定日期2025-12-18

產品代碼DQK

諮詢委員會履歷

決定相當於

器材摘要

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2025-12-18 under 510(k) number K252533. 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 Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is a medical device that received FDA 510(k) clearance on 2025-12-18. The listed applicant is Edwards Lifesciences. The 510(k) number is K252533.

When did HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) receive FDA 510(k) clearance?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) received FDA 510(k) clearance on 2025-12-18, under 510(k) number K252533.

Who is the listed applicant for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

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 Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1)?

The FDA product code for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1; ALTACR1; ALTASR1) is DQK.

其他以 Edwards Lifesciences 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。

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 K253034HemoSphere 流模組 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)

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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。

K261729EnSite™ X EP 系統Abbott Medical K262005Affera 整合地圖系統Medtronic, Inc.K253692AVVIGO™+ 多模態導引系統Boston Scientific K253576CorVista System® 內建 PCWP 附加功能Analytics For Life, Inc.K262006EnSite™ X EP 系統Abbott Medical K252978ScioCardio 心電圖分析平台Synergen Technology Labs, LLC

官方來源

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