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FDA 510(k)

世紀灌流系統

K 號：K202125 · 2021-03-07

申請人Century Hlm, LLC
決定日期2021-03-07
產品代碼DTQ
諮詢委員會履歷
決定相當於

器材摘要

Century Perfusion System is the device name listed in this FDA 510(k) record. The listed applicant is Century Hlm, LLC. It received FDA 510(k) clearance on 2021-03-07 under 510(k) number K202125. The device is classified under product code DTQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Century Perfusion System?

Century Perfusion System is a medical device that received FDA 510(k) clearance on 2021-03-07. The listed applicant is Century Hlm, LLC. The 510(k) number is K202125.

When did Century Perfusion System receive FDA 510(k) clearance?

Century Perfusion System received FDA 510(k) clearance on 2021-03-07, under 510(k) number K202125.

Who is the listed applicant for Century Perfusion System?

The FDA 510(k) record lists Century Hlm, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Century Perfusion System?

The FDA product code for Century Perfusion System is DTQ.

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

相關器械（代碼：DTQ）

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。

K232291Essenz HLM, Essenz ILBMLivanova Deutschland, GmbHK221895特魯美先進灌流系統 1Terumo Cardiovascular Systems CorporationK221373Essenz HLMLivanova Deutschland, GmbHK210130Stockert S5 系統Livanova Deutschland, GmbHK190282量子智慧閉塞器 LH（左手），量子智慧閉塞器 LH（右手）Spectrum Medical , Ltd.K173834量子泵控制台Spectrum Medical , Ltd.

官方來源

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