Selectra Lead Implantation System
K 號：K222037 · 2022-07-19
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器材摘要
Selectra Lead Implantation System is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. It received FDA 510(k) clearance on 2022-07-19 under 510(k) number K222037. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Selectra Lead Implantation System?
Selectra Lead Implantation System is a medical device that received FDA 510(k) clearance on 2022-07-19. The listed applicant is Biotronik, Inc.. The 510(k) number is K222037.
When did Selectra Lead Implantation System receive FDA 510(k) clearance?
Selectra Lead Implantation System received FDA 510(k) clearance on 2022-07-19, under 510(k) number K222037.
Who is the listed applicant for Selectra Lead Implantation System?
The FDA 510(k) record lists Biotronik, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Selectra Lead Implantation System?
The FDA product code for Selectra Lead Implantation System is DQY.
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其他以 Biotronik, Inc. 為申請人之記錄
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相關器械（代碼：DQY）
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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