Pacel Flow 定向起搏心导管
K 號：K161873 · 2016-11-22
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器材摘要
Pacel Flow Directed Pacing Catheter is the device name listed in this FDA 510(k) record. The listed applicant is St Jude Medical. It received FDA 510(k) clearance on 2016-11-22 under 510(k) number K161873. The device is classified under product code LDF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Pacel Flow Directed Pacing Catheter?
Pacel Flow Directed Pacing Catheter is a medical device that received FDA 510(k) clearance on 2016-11-22. The listed applicant is St Jude Medical. The 510(k) number is K161873.
When did Pacel Flow Directed Pacing Catheter receive FDA 510(k) clearance?
Pacel Flow Directed Pacing Catheter received FDA 510(k) clearance on 2016-11-22, under 510(k) number K161873.
Who is the listed applicant for Pacel Flow Directed Pacing Catheter?
The FDA 510(k) record lists St Jude Medical as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Pacel Flow Directed Pacing Catheter?
The FDA product code for Pacel Flow Directed Pacing Catheter is LDF.
相關臨床試驗
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其他以 St Jude Medical 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：LDF）
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
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