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FDA 510(k)

Swan-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）

K 號：K233983 · 2024-06-27

申請人Edwards Lifesciences
決定日期2024-06-27
產品代碼DYG
諮詢委員會履歷
決定相當於

器材摘要

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233983. 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 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)?

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Edwards Lifesciences. The 510(k) number is K233983.

When did Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) receive FDA 510(k) clearance?

Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233983.

Who is the listed applicant for Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)?

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 Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100)?

The FDA product code for Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) 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。

K242451HemoSphere 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）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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