• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back To Search Results
Device Classification Name device, neurovascular embolization
510(k) Number K203625
Device Name Numen Coil Embolization System; NumenFR Detachment System
MicroPort NeuroTech (Shanghai) Co., Ltd.
16th Building, 222 Guangdan Road, Pudong New District
Shanghai,  CN 201318
Applicant Contact Qiuhua Zou
BioDesign Regulatory Services, LLC
16185 Los Gatos Blvd, Suite 205
Los Gatos,  CA  95032
Correspondent Contact Ivory Chang
Regulation Number882.5950
Classification Product Code
Subsequent Product Code
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