Kossel Medtech (Suzhou) Co., Ltd. FDA Approvals

0 new drug approvals and 5 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
NC PTA Balloon Dilatation Catheter510(k)Sep 16, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 16, 2026
HP PTA Balloon Dilatation Catheter510(k)Dec 20, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 20, 2023
PTA Balloon Dilatation Catheter510(k)Dec 14, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 14, 2022
Selebrek PTCA Balloon Dilatation Catheter510(k)Jan 7, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jan 7, 2022
Selethru(TM) NC PTCA Balloon Dilatation Catheter510(k)Jul 2, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jul 2, 2021