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FDA 510(k)

峰值左心室輸出管，20 Fr；峰值左心室輸出管，18 Fr；峰值左心室輸出管，16 Fr

K 號：K170488 · 2017-08-10

申請人Surge Cardiovascular
決定日期2017-08-10
產品代碼DWF
諮詢委員會履歷
決定相當於

器材摘要

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is the device name listed in this FDA 510(k) record. The listed applicant is Surge Cardiovascular. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K170488. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Surge Cardiovascular. The 510(k) number is K170488.

When did Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr receive FDA 510(k) clearance?

Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr received FDA 510(k) clearance on 2017-08-10, under 510(k) number K170488.

Who is the listed applicant for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

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

What is the FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr?

The FDA product code for Peak Left Ventricular Vent Cannula, 20 Fr.; Peak Left Ventricular Vent Cannula, 18 Fr; Peak Left Ventricular Vent Cannula, 16 Fr is DWF.

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：DWF）

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。

K260195延長式單件動脈（EOPA）3D™ 運動脈管Medtronic, Inc.K250937靜脈回流針管LivaNova USA, Inc.K260043智能反應器迷彩塗層循環離身心肺管路組（SR180C）Smart ReactorsK253203後向冠狀動脈 sinus 灌注針管Medtronic, Inc.K253671雙階段靜脈針管Sorin Group Italia S.R.L.K253998清晰視內冠狀動脈分流器Medtronic, Inc.

官方來源

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