FDA 510(k)

Numen™ 赫利亞栓塞系統；NumenFR™ 分離系統

K 號：K260351 · 2026-05-20

申請人MicroPort NeuroTech (Shanghai) Co., Ltd.

決定日期2026-05-20

產品代碼HCG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is the device name listed in this FDA 510(k) record. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. It received FDA 510(k) clearance on 2026-05-20 under 510(k) number K260351. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is a medical device that received FDA 510(k) clearance on 2026-05-20. The listed applicant is MicroPort NeuroTech (Shanghai) Co., Ltd.. The 510(k) number is K260351.

When did Numen™ Helia Coil Embolization System; NumenFR™ Detachment System receive FDA 510(k) clearance?

Numen™ Helia Coil Embolization System; NumenFR™ Detachment System received FDA 510(k) clearance on 2026-05-20, under 510(k) number K260351.

Who is the listed applicant for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

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

What is the FDA product code for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System?

The FDA product code for Numen™ Helia Coil Embolization System; NumenFR™ Detachment System is HCG.

其他以 MicroPort NeuroTech (Shanghai) Co., Ltd. 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。

K242154Numen™ 絲圈栓塞系統；NumenFR™ 分離系統 K232955Numen 結節栓塞系統；NumenFR 分離系統 K203625Numen 結節栓塞系統；NumenFR 分離系統

相關器械（代碼：HCG）

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。

官方來源

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