FDA 510(k)Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
K 號：K161249 · 2016-08-19
決定日期2016-08-19
產品代碼LDF
諮詢委員會CV
決定Substantially Equivalent
器材摘要
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2016-08-19 under 510(k) number K161249. 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 Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is a medical device that received FDA 510(k) clearance on 2016-08-19. The listed applicant is Medtronic. The 510(k) number is K161249.
When did Streamline 6495 Bipolar Temporary Myocardial Pacing Lead receive FDA 510(k) clearance?
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead received FDA 510(k) clearance on 2016-08-19, under 510(k) number K161249.
Who is the listed applicant for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead?
The FDA product code for Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is LDF.
相關臨床試驗
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其他以 Medtronic 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。
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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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