Achieve ST 地圖導管，導管連接電纜
K 號：K153139 · 2016-05-06
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器材摘要
Achieve ST Mapping Catheter, Catheter Connecting Cable is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2016-05-06 under 510(k) number K153139. The device is classified under product code DRF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Achieve ST Mapping Catheter, Catheter Connecting Cable?
Achieve ST Mapping Catheter, Catheter Connecting Cable is a medical device that received FDA 510(k) clearance on 2016-05-06. The listed applicant is Medtronic, Inc.. The 510(k) number is K153139.
When did Achieve ST Mapping Catheter, Catheter Connecting Cable receive FDA 510(k) clearance?
Achieve ST Mapping Catheter, Catheter Connecting Cable received FDA 510(k) clearance on 2016-05-06, under 510(k) number K153139.
Who is the listed applicant for Achieve ST Mapping Catheter, Catheter Connecting Cable?
FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。
What is the FDA product code for Achieve ST Mapping Catheter, Catheter Connecting Cable?
The FDA product code for Achieve ST Mapping Catheter, Catheter Connecting Cable is DRF.
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 Medtronic, Inc. 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：DRF）
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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