Lake Region Medical 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
Enroute 0.014'' Transcarotid Guidewire510(k)Mar 19, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Mar 19, 2026
PTFE Guidewire510(k)Dec 6, 2024Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Special)	Dec 6, 2024
Pre-Formed Blue510(k)Oct 7, 2022Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Oct 7, 2022
Pre-Formed Extra Support Guidewire510(k)Nov 22, 2021Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Nov 22, 2021