Dongguan TT Medical, Inc. FDA Approvals

0 new drug approvals and 6 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
Valvuloplasty Balloon Catheter (ValvuloPro)510(k)Mar 20, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 20, 2026
ValvuloPro Valvuloplasty Balloon Catheter510(k)Jul 31, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 31, 2024
ValvuloPro Valvuloplasty Balloon Catheter510(k)Oct 12, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 12, 2023
Coronary Dilatation Balloon Catheter (VesPenetrator®), Coronary Dilatation Balloon Catheter (VesTraveler®), Coronary Dilatation Balloon Catheter (VexPander®)510(k)Jun 29, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 29, 2023
MultiStage Balloon Dilatation Catheter510(k)Mar 9, 2023Gastroenterology, Urology	Gastroenterology, Urology	510(k)Substantially Equivalent (Traditional)	Mar 9, 2023
Multistage Balloon Dilatation Catheter510(k)Mar 1, 2023Ear, Nose, Throat	Ear, Nose, Throat	510(k)Substantially Equivalent (Traditional)	Mar 1, 2023