鵠甘氏心导管
K 號：K233824 · 2024-06-06
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器材摘要
Swan-Ganz catheter is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2024-06-06 under 510(k) number K233824. 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 catheter?
Swan-Ganz catheter is a medical device that received FDA 510(k) clearance on 2024-06-06. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K233824.
When did Swan-Ganz catheter receive FDA 510(k) clearance?
Swan-Ganz catheter received FDA 510(k) clearance on 2024-06-06, under 510(k) number K233824.
Who is the listed applicant for Swan-Ganz catheter?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Swan-Ganz catheter?
The FDA product code for Swan-Ganz catheter 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。
其他以 Edwards Lifesciences, LLC 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。
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 LifesciencesK233983Swan-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 LifesciencesK231248Swan-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
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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