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FDA 510(k)

HemoDraw Plus 關閉式血液採樣系統搭配 LogiCal 轉換器套件，HemoDraw Plus 關閉式血液採樣系統搭配 Transtar 轉換器套件

K 號：K172458 · 2017-11-09

申請人Smiths Medical Asd, Inc.
決定日期2017-11-09
產品代碼DRS
諮詢委員會履歷
決定相當於

器材摘要

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit is the device name listed in this FDA 510(k) record. The listed applicant is Smiths Medical Asd, Inc.. It received FDA 510(k) clearance on 2017-11-09 under 510(k) number K172458. The device is classified under product code DRS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit?

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit is a medical device that received FDA 510(k) clearance on 2017-11-09. The listed applicant is Smiths Medical Asd, Inc.. The 510(k) number is K172458.

When did HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit receive FDA 510(k) clearance?

HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit received FDA 510(k) clearance on 2017-11-09, under 510(k) number K172458.

Who is the listed applicant for HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit?

The FDA 510(k) record lists Smiths Medical Asd, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit?

The FDA product code for HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit is DRS.

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

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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：DRS）

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。

K254074真壓Procerus EnterprisesK242909FloTrac感測器；FloTrac Jr感測器；Acumen IQ感測器；VolumeView感測器Edwards Lifesciences, LLCK221782Meritrans ECO 可重用壓力傳感器，Meritrans ECO 球帽Merit Medical Pte. , Ltd.K163172HemoDraw Plus 關閉式血液採樣系統搭配 LogiCal 轉換器套件，HemoDraw Plus 關閉式血液採樣系統搭配 Transtar 轉換器套件Smiths Medical Asd, Inc.K161408羅盤針與MAPCenturion Medical Products CorporationK152472一次性壓力傳感器Zhejiang Haisheng Medical Device Co., Ltd.

官方來源

在 FDA 資料庫中查看 →

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