Polaris X™ 雙向導向診斷導管
K 號：K233207 · 2023-10-27
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器材摘要
Polaris X™ Unidirectional Steerable Diagnostic Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2023-10-27 under 510(k) number K233207. 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 Polaris X™ Unidirectional Steerable Diagnostic Catheter?
Polaris X™ Unidirectional Steerable Diagnostic Catheter is a medical device that received FDA 510(k) clearance on 2023-10-27. The listed applicant is Boston Scientific Corporation. The 510(k) number is K233207.
When did Polaris X™ Unidirectional Steerable Diagnostic Catheter receive FDA 510(k) clearance?
Polaris X™ Unidirectional Steerable Diagnostic Catheter received FDA 510(k) clearance on 2023-10-27, under 510(k) number K233207.
Who is the listed applicant for Polaris X™ Unidirectional Steerable Diagnostic Catheter?
FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。
What is the FDA product code for Polaris X™ Unidirectional Steerable Diagnostic Catheter?
The FDA product code for Polaris X™ Unidirectional Steerable Diagnostic Catheter 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 Boston Scientific Corporation 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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