Shanghai MicroPort Medical (Group) Co., Ltd. FDA Approvals

0 new drug approvals and 2 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
Firefighter Pro PTCA Balloon Catheter510(k)Apr 7, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Apr 7, 2026
Firefighter NC Pro PTCA Balloon Catheter510(k)Jul 21, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 21, 2023