FDA 510(k)

Cook Turbo-Flo HD 急性血液透析腔管組合/托盤

K 號：K161504 · 2017-01-06

決定日期2017-01-06

產品代碼MPB

諮詢委員會GU

決定Unknown

器材摘要

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is the device name listed in this FDA 510(k) record. The listed applicant is Cook Incorporated. It received FDA 510(k) clearance on 2017-01-06 under 510(k) number K161504. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is a medical device that received FDA 510(k) clearance on 2017-01-06. The listed applicant is Cook Incorporated. The 510(k) number is K161504.

When did Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray receive FDA 510(k) clearance?

Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray received FDA 510(k) clearance on 2017-01-06, under 510(k) number K161504.

Who is the listed applicant for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

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

What is the FDA product code for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray?

The FDA product code for Cook Turbo-Flo HD Acute Hemodialysis Catheter Set/Tray is MPB.

其他以 Cook Incorporated 為申請人之記錄

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相關器械（代碼：MPB）

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。

K25083614F Duo-Flow® Side X Side Double Lumen CatheterMedical Components, Inc.K200426急性雙腔血液透析導管Health Line International Corporation K192807雙向流側側雙腔導管Medical Components, Inc. (dba MedComp)K192302馬胡卡克急性單腔導管，馬胡卡克急性雙腔導管，馬胡卡克急性三腔導管，馬胡卡克急性高壓三腔導管Covidien, LLC K163458Zenysis 短期透析導管C.R. Bard, Inc.K153190Zenysis 短期透析導管C.R. Bard, Inc.

官方來源

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