FDA 510(k)

清晰視內冠狀動脈分流器

K 號：K253998 · 2026-01-20

決定日期2026-01-20

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Clearview Intracoronary Shunts is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-01-20 under 510(k) number K253998. 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 Clearview Intracoronary Shunts?

Clearview Intracoronary Shunts is a medical device that received FDA 510(k) clearance on 2026-01-20. The listed applicant is Medtronic, Inc.. The 510(k) number is K253998.

When did Clearview Intracoronary Shunts receive FDA 510(k) clearance?

Clearview Intracoronary Shunts received FDA 510(k) clearance on 2026-01-20, under 510(k) number K253998.

Who is the listed applicant for Clearview Intracoronary Shunts?

FDA 510(k) 記錄將美敦力公司（Medtronic, Inc.）列為申請人。這並不單獨確立該設備製造商。

What is the FDA product code for Clearview Intracoronary Shunts?

The FDA product code for Clearview Intracoronary Shunts is DWF.

其他以 Medtronic, 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。

K262913Protégé™ EverFlex™ 自擴張週邊支架系統 K262735LINQ II 可植入式心臟監護器 (ICM) (LNQ22)K262005Affera 整合地圖系統 K261335VitalFlow Set with Balance™ 生物表面 K261866Concerto Versa™ 可拆式線圈 K260195延長式單件動脈（EOPA）3D™ 運動脈管

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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 Reactors K253203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.K253106AngioVac 管套AngioDynamics, Inc.

官方來源

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資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。