FDA 510(k)

X-Wire 導絲

K 號：K244061 · 2025-08-26

決定日期2025-08-26

產品代碼MOF

諮詢委員會履歷

決定相當於

器材摘要

X-Wire Guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Imperative Care, Inc.. It received FDA 510(k) clearance on 2025-08-26 under 510(k) number K244061. 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 X-Wire Guidewire?

X-Wire Guidewire is a medical device that received FDA 510(k) clearance on 2025-08-26. The listed applicant is Imperative Care, Inc.. The 510(k) number is K244061.

When did X-Wire Guidewire receive FDA 510(k) clearance?

X-Wire Guidewire received FDA 510(k) clearance on 2025-08-26, under 510(k) number K244061.

Who is the listed applicant for X-Wire Guidewire?

FDA 510(k) 記錄將 Imperative Care, Inc. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for X-Wire Guidewire?

The FDA product code for X-Wire Guidewire is MOF.

其他以 Imperative Care, 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：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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