FDA 510(k)

Numen® Helia 球囊栓塞系统；NumenFR® 分离系统

K号: K260351 · 2026-05-20

申请人MicroPort NeuroTech (Shanghai) Co., Ltd.

决定日期2026-05-20

产品代码HCG

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决定实质等同

器械摘要

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.

常见问题

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.

列明MicroPort NeuroTech (Shanghai) Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K242154Numen® 球囊栓塞系统；NumenFR® 分离系统 K232955Numen 球囊栓塞系统；NumenFR 分离系统 K203625Numen 球囊栓塞系统；NumenFR 分离系统

相关器械（代码：HCG）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

官方来源

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