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 ID: K203625
• 510k Number: K203625
• Device Name: Numen Coil Embolization System; NumenFR Detachment System
• Classification: Device, Neurovascular Embolization
• Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd. 16th Building, 222 Guangdan Road, Pudong New District Shanghai, CN 201318
• Contact: Qiuhua Zou
• Correspondent: Ivory Chang; BioDesign Regulatory Services, LLC 16185 Los Gatos Blvd, Suite 205 Los Gatos, CA 95032
• Product Code: HCG
• CFR Regulation Number: 882.5950 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-12-11
• Decision Date: 2021-09-01

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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