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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Neurovascular Embolization
510(k) Number K260351
Device Name Numen™ Helia Coil Embolization System; NumenFR™ Detachment System
Applicant
MicroPort NeuroTech (Shanghai) Co., Ltd.
Bldg.#16, 222 Guangdan Rd., Pudong New District
Shanghai,  CN 201318
Applicant Contact Yuying Chen
Correspondent
MicroPort CRM USA, Inc.
5677 Airport Rd.
Arlington,  TN  38002
Correspondent Contact John Skousen
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received02/03/2026
Decision Date 05/20/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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