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FDA 510(k)

14F Duo-Flow® Side X Side Double Lumen Catheter

K 號：K250836 · 2025-08-12

申請人Medical Components, Inc.
決定日期2025-08-12
產品代碼MPB
諮詢委員會GU
決定相當於

器材摘要

14F Duo-Flow® Side X Side Double Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medical Components, Inc.. It received FDA 510(k) clearance on 2025-08-12 under 510(k) number K250836. The device is classified under product code MPB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the 14F Duo-Flow® Side X Side Double Lumen Catheter?

14F Duo-Flow® Side X Side Double Lumen Catheter is a medical device that received FDA 510(k) clearance on 2025-08-12. The listed applicant is Medical Components, Inc.. The 510(k) number is K250836.

When did 14F Duo-Flow® Side X Side Double Lumen Catheter receive FDA 510(k) clearance?

14F Duo-Flow® Side X Side Double Lumen Catheter received FDA 510(k) clearance on 2025-08-12, under 510(k) number K250836.

Who is the listed applicant for 14F Duo-Flow® Side X Side Double Lumen Catheter?

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

What is the FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter?

The FDA product code for 14F Duo-Flow® Side X Side Double Lumen Catheter is MPB.

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：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。

K200426急性雙腔血液透析導管Health Line International CorporationK192807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, LLCK163458Zenysis 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 IncorporatedK153190Zenysis 短期透析導管C.R. Bard, Inc.

官方來源

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