Shanghai Heartcare Medical Technology Co., Ltd. FDA Approvals

0 new drug approvals and 3 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
Distal Access Catheter510(k)Dec 22, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 22, 2023
Micro Catheter510(k)Feb 10, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Feb 10, 2022
Balloon Guiding Catheter510(k)Aug 25, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Aug 25, 2021