FDA 510(k)

延長式單件動脈（EOPA）3D™ 運動脈管

K 號：K260195 · 2026-04-23

決定日期2026-04-23

產品代碼DWF

諮詢委員會履歷

決定相當於

器材摘要

Elongated One-Piece Arterial (EOPA) 3D™ Arterial 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 2026-04-23 under 510(k) number K260195. 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 Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae is a medical device that received FDA 510(k) clearance on 2026-04-23. The listed applicant is Medtronic, Inc.. The 510(k) number is K260195.

When did Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae receive FDA 510(k) clearance?

Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae received FDA 510(k) clearance on 2026-04-23, under 510(k) number K260195.

Who is the listed applicant for Elongated One-Piece Arterial (EOPA) 3D™ Arterial 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 Elongated One-Piece Arterial (EOPA) 3D™ Arterial Cannulae?

The FDA product code for Elongated One-Piece Arterial (EOPA) 3D™ Arterial 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。

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官方來源

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