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FDA 510(k)

HemoSphere Alta先進監測平台（ALTAALL1/ALTCR1/ALTASR1）；HemoSphere Alta- 壓力監測線（HEMAPSC200）；Acumen AFM線- HemoSphere Alta監測器（HEMAFM100）

K 號：K242451 · 2024-12-09

申請人Edwards Lifesciences
決定日期2024-12-09
產品代碼DYG
諮詢委員會履歷
決定相當於

器材摘要

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-12-09 under 510(k) number K242451. The device is classified under product code DYG. 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/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) is a medical device that received FDA 510(k) clearance on 2024-12-09. The listed applicant is Edwards Lifesciences. The 510(k) number is K242451.

When did HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) receive FDA 510(k) clearance?

HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) received FDA 510(k) clearance on 2024-12-09, under 510(k) number K242451.

Who is the listed applicant for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)?

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/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100)?

The FDA product code for HemoSphere Alta Advanced Monitoring Platform (ALTAALL1/ALTCR1/ALTASR1); HemoSphere Alta- monitor pressure cable (HEMAPSC200);Acumen AFM cable- HemoSphere Alta monitor (HEMAFM100) is DYG.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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K252533HemoSphere Alta先進監控平台（ALTAALL1；ALTACR1；ALTASR1）K253034HemoSphere 流模組K252364愛德華eSheath Optima引導套件

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相關器械（代碼：DYG）

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。

K233983Swan-Ganz 計時探針及心导管；Swan-Ganz 兩極計時心导管（D97120F5）；Swan-Ganz 兩極計時心导管（D97130F5）；Swan-Ganz 計時濕度測量 TD 心导管（D200F7）；Chandler 轉透膜 V 計時探針（D98100）Edwards LifesciencesK233824鵠甘氏心导管Edwards Lifesciences, LLCK231248Swan-Ganz 緝子，FloTrac 感應器，ClearSight 手環，HemoSphere 先進監測平台Edwards Lifesciencess, LLCK222117Swang-Ganz IQ 肺動脈針Edwards Lifesiences, LLCK193466鵠甘導管Edwards Lifesciences, LLCK160084鵠全心臟導管Edwards Lifesciences, LLC

官方來源

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