Natec Medical , 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
Amethyst HP PTA OTW 0.035 Catheter510(k)Dec 18, 2025Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 18, 2025
Amethyst HP PTA OTW 0.035 Catheter510(k)Dec 18, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 18, 2024
Ebony HP PTA OTW 0.035 Catheter510(k)Jun 29, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Jun 29, 2022
Tamarin Blue PTCA RX Dilatation Catheter510(k)Jul 9, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Jul 9, 2021