FDA 510(k)

Zenysis 短期透析導管

K 號：K163458 · 2017-04-04

決定日期2017-04-04

產品代碼MPB

諮詢委員會GU

決定Unknown

器材摘要

Zenysis Short-Term Dialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K163458. 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 Zenysis Short-Term Dialysis Catheter?

Zenysis Short-Term Dialysis Catheter is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163458.

When did Zenysis Short-Term Dialysis Catheter receive FDA 510(k) clearance?

Zenysis Short-Term Dialysis Catheter received FDA 510(k) clearance on 2017-04-04, under 510(k) number K163458.

Who is the listed applicant for Zenysis Short-Term Dialysis Catheter?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zenysis Short-Term Dialysis Catheter?

The FDA product code for Zenysis Short-Term Dialysis Catheter is MPB.

其他以 C.R. Bard, Inc. 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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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 K161504Cook Turbo-Flo HD 急性血液透析腔管組合/托盤Cook Incorporated K153190Zenysis 短期透析導管C.R. Bard, Inc.

官方來源

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