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FDA 510(k)

DCwire 微導絲

K 號：K252122 · 2026-03-16

申請人Shanghai Achieva Medical Suzhou Co., Ltd.
決定日期2026-03-16
產品代碼MOF
諮詢委員會履歷
決定相當於

器材摘要

DCwire Micro-guidewire is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2026-03-16 under 510(k) number K252122. 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 DCwire Micro-guidewire?

DCwire Micro-guidewire is a medical device that received FDA 510(k) clearance on 2026-03-16. The listed applicant is Shanghai Achieva Medical Suzhou Co., Ltd.. The 510(k) number is K252122.

When did DCwire Micro-guidewire receive FDA 510(k) clearance?

DCwire Micro-guidewire received FDA 510(k) clearance on 2026-03-16, under 510(k) number K252122.

Who is the listed applicant for DCwire Micro-guidewire?

The FDA 510(k) record lists Shanghai Achieva Medical Suzhou Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DCwire Micro-guidewire?

The FDA product code for DCwire Micro-guidewire is MOF.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 VascularK26075135 鏈環導絲Piraeus Medical, Inc.K262424Willow 12 導絲Arbor Endovascular, LLCK260223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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