Numen Coil Embolization System; NumenFR Detachment System

Device, Neurovascular Embolization

MicroPort NeuroTech (Shanghai) Co., Ltd.

The following data is part of a premarket notification filed by Microport Neurotech (shanghai) Co., Ltd. with the FDA for Numen Coil Embolization System; Numenfr Detachment System.

Pre-market Notification Details

Device IDK203625
510k NumberK203625
Device Name:Numen Coil Embolization System; NumenFR Detachment System
ClassificationDevice, Neurovascular Embolization
Applicant MicroPort NeuroTech (Shanghai) Co., Ltd. 16th Building, 222 Guangdan Road, Pudong New District Shanghai,  CN 201318
ContactQiuhua Zou
CorrespondentIvory Chang
BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd, Suite 205 Los Gatos,  CA  95032
Product CodeHCG  
CFR Regulation Number882.5950 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-11
Decision Date2021-09-01

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