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 Building, 222 Guangdan Road, 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 Number | 882.5950
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/11/2020 |
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
|
|
|