Numen Coil Embolization System; NumenFR Detachment System— 510(k) K203625

Substantially Equivalent

MicroPort NeuroTech (Shanghai) Co., Ltd.

FDA 510(k) clearance K203625 for Numen Coil Embolization System; NumenFR Detachment System, Substantially Equivalent on 2021-09-01. Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd..

Clearance details

Applicant: MicroPort NeuroTech (Shanghai) Co., Ltd.
Product code: Code HCG
Advisory panel: Neurology
Date received: 2020-12-11
Decision date: 2021-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shanghai, CN

Download summary PDF View on FDA.gov ↗

Adverse events under product code HCG

product code HCG

Death: 50
Injury: 801
Malfunction: 5,625
Total: 6,476

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.