Trisalus Life Sciences 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
TriSalus TriNav Advance Infusion System510(k)Sep 21, 2026Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Sep 21, 2026
TriSalus TriGuideTM Guiding Catheter510(k)Dec 27, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	Dec 27, 2023
TriSalus TriNav® LV Infusion System510(k)May 2, 2023Cardiovascular	Cardiovascular	510(k)Substantially Equivalent (Traditional)	May 2, 2023