FDA 510(k)

後向冠狀動脈 sinus 灌注針管

K 號：K253203 · 2026-02-19

決定日期2026-02-19

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Retrograde Coronary Sinus Perfusion Cannulae is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-02-19 under 510(k) number K253203. 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 Retrograde Coronary Sinus Perfusion Cannulae?

Retrograde Coronary Sinus Perfusion Cannulae is a medical device that received FDA 510(k) clearance on 2026-02-19. The listed applicant is Medtronic, Inc.. The 510(k) number is K253203.

When did Retrograde Coronary Sinus Perfusion Cannulae receive FDA 510(k) clearance?

Retrograde Coronary Sinus Perfusion Cannulae received FDA 510(k) clearance on 2026-02-19, under 510(k) number K253203.

Who is the listed applicant for Retrograde Coronary Sinus Perfusion Cannulae?

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 Retrograde Coronary Sinus Perfusion Cannulae?

The FDA product code for Retrograde Coronary Sinus Perfusion Cannulae 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。

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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 K253671雙階段靜脈針管Sorin Group Italia S.R.L.K253998清晰視內冠狀動脈分流器Medtronic, Inc.K253106AngioVac 管套AngioDynamics, Inc.

官方來源

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