Tempo 暫時性起搏導管
K 號：K160260 · 2016-10-25
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器材摘要
Tempo Temporary Pacing Lead is the device name listed in this FDA 510(k) record. The listed applicant is Biotrace Medical, Inc.. It received FDA 510(k) clearance on 2016-10-25 under 510(k) number K160260. 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 Tempo Temporary Pacing Lead?
Tempo Temporary Pacing Lead is a medical device that received FDA 510(k) clearance on 2016-10-25. The listed applicant is Biotrace Medical, Inc.. The 510(k) number is K160260.
When did Tempo Temporary Pacing Lead receive FDA 510(k) clearance?
Tempo Temporary Pacing Lead received FDA 510(k) clearance on 2016-10-25, under 510(k) number K160260.
Who is the listed applicant for Tempo Temporary Pacing Lead?
The FDA 510(k) record lists Biotrace Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Tempo Temporary Pacing Lead?
The FDA product code for Tempo Temporary Pacing Lead is LDF.
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。
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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