FDA 510(k)

急性雙腔血液透析導管

K 號：K200426 · 2020-12-24

申請人Health Line International Corporation

決定日期2020-12-24

產品代碼MPB

諮詢委員會GU

決定Unknown

器材摘要

Acute Dual Lumen Hemodialysis Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Health Line International Corporation. It received FDA 510(k) clearance on 2020-12-24 under 510(k) number K200426. 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 Acute Dual Lumen Hemodialysis Catheter?

Acute Dual Lumen Hemodialysis Catheter is a medical device that received FDA 510(k) clearance on 2020-12-24. The listed applicant is Health Line International Corporation. The 510(k) number is K200426.

When did Acute Dual Lumen Hemodialysis Catheter receive FDA 510(k) clearance?

Acute Dual Lumen Hemodialysis Catheter received FDA 510(k) clearance on 2020-12-24, under 510(k) number K200426.

Who is the listed applicant for Acute Dual Lumen Hemodialysis Catheter?

The FDA 510(k) record lists Health Line International Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acute Dual Lumen Hemodialysis Catheter?

The FDA product code for Acute Dual Lumen Hemodialysis Catheter is MPB.

其他以 Health Line International Corporation 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。

K261950健康線拆離導入器 K222170功率急性三腔血液透析导管 K200263健康線CT中線心导管 K192533健康線 CT CVC K160448ARTLINE

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.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.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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