Shanghai Microport EP Medtech 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
EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping Catheter510(k)Dec 30, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 30, 2022
PathBuilder Transseptal Needle510(k)Mar 23, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 23, 2022
PathBuilder Transseptal Guiding Introducer510(k)Mar 23, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Mar 23, 2022
PathBuilder Steerable Introducer510(k)Feb 8, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 8, 2022