MicroPort NeuroTech (Shanghai) Co., Ltd. FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Numen Helia Coil Embolization System; NumenFR Detachment System510(k)May 20, 2026Neurology	Neurology	510(k)Substantially Equivalent (Special)	May 20, 2026
Numen Coil Embolization System; NumenFR Detachment System510(k)Sep 30, 2024Neurology	Neurology	510(k)Substantially Equivalent (Special)	Sep 30, 2024
Numen Coil Embolization System; NumenFR Detachment System510(k)Jan 10, 2024Neurology	Neurology	510(k)Substantially Equivalent (Special)	Jan 10, 2024
Numen Coil Embolization System; NumenFR Detachment System510(k)Sep 1, 2021Neurology	Neurology	510(k)Substantially Equivalent (Traditional)	Sep 1, 2021