鵠甘導管
K 號：K193466 · 2020-02-16
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器材摘要
Swan-Ganz Catheters 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 2020-02-16 under 510(k) number K193466. 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 Catheters?
Swan-Ganz Catheters is a medical device that received FDA 510(k) clearance on 2020-02-16. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K193466.
When did Swan-Ganz Catheters receive FDA 510(k) clearance?
Swan-Ganz Catheters received FDA 510(k) clearance on 2020-02-16, under 510(k) number K193466.
Who is the listed applicant for Swan-Ganz Catheters?
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 Catheters?
The FDA product code for Swan-Ganz Catheters is DYG.
相關臨床試驗
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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。
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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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