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FDA 510(k)

小型（4）輪壓泵用於泰尔茂先進灌流系統1，大型（6）輪壓泵用於泰尔茂先進灌流系統1

K 號：K162843 · 2016-11-17

申請人Terumo Cardiovascular Systems Corporation
決定日期2016-11-17
產品代碼DWB
諮詢委員會履歷
決定相當於

器材摘要

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Cardiovascular Systems Corporation. It received FDA 510(k) clearance on 2016-11-17 under 510(k) number K162843. The device is classified under product code DWB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1?

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 is a medical device that received FDA 510(k) clearance on 2016-11-17. The listed applicant is Terumo Cardiovascular Systems Corporation. The 510(k) number is K162843.

When did Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 receive FDA 510(k) clearance?

Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 received FDA 510(k) clearance on 2016-11-17, under 510(k) number K162843.

Who is the listed applicant for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1?

The FDA 510(k) record lists Terumo Cardiovascular Systems Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1?

The FDA product code for Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump for the Terumo Advanced Perfusion System 1 is DWB.

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Terumo Cardiovascular Systems 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。

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