FDA 510(k)

Willow 24 導絲

K 號：K260537 · 2026-03-19

決定日期2026-03-19

產品代碼MOF

諮詢委員會履歷

決定相當於

器材摘要

Willow 24 Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Arbor Endovascular, LLC. It received FDA 510(k) clearance on 2026-03-19 under 510(k) number K260537. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Willow 24 Guidewire?

Willow 24 Guidewire is a medical device that received FDA 510(k) clearance on 2026-03-19. The listed applicant is Arbor Endovascular, LLC. The 510(k) number is K260537.

When did Willow 24 Guidewire receive FDA 510(k) clearance?

Willow 24 Guidewire received FDA 510(k) clearance on 2026-03-19, under 510(k) number K260537.

Who is the listed applicant for Willow 24 Guidewire?

FDA 510(k) 記錄將 Arbor Endovascular, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Willow 24 Guidewire?

The FDA product code for Willow 24 Guidewire is MOF.

其他以 Arbor Endovascular, LLC 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。

K262424Willow 12 導絲 K260130Willow 18 導絲 K2531680.014” Willow Guidewire K2437560.014” Willow Guidewire

相關器械（代碼：MOF）

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。

K254181亞里士多德65宏線Scientia Vascular K26075135 鏈環導絲Piraeus Medical, Inc.K262424Willow 12 導絲Arbor Endovascular, LLC K260223亞里士多德迷你導絲Scientia Vascular, Inc.K254006Drivewire 35 導絲Rapid Medical Ltd.K253579Aristotle 14 導絲；Aristotle 18 導絲；Aristotle 24 導絲；Zoom Wire 14 導絲Scientia Vascular, Inc.

官方來源

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