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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 K203625
Device Name Numen Coil Embolization System; NumenFR Detachment System
Applicant
MicroPort NeuroTech (Shanghai) Co., Ltd.
16th Bldg. , 222 Guangdan Rd., Pudong New District
Shanghai,  CN 201318
Applicant Contact Qiuhua Zou
Correspondent
Biodesign Regulatory Services, LLC
16185 Los Gatos Blvd., Suite 205
Los Gatos,  CA  95032
Correspondent Contact Ivory Chang
Regulation Number882.5950
Classification Product Code
HCG  
Subsequent Product Code
KRD  
Date Received12/11/2020
Decision Date 09/01/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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