510(k) clearance

TriSalus TriNav Advance Infusion System

FDA 510(k) source

510(k) number

K253509

Applicant

Trisalus Life Sciences

Decision date

Sep 21, 2026

Date received

Nov 5, 2025

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KRA

Device type

Catheter, Continuous Flush

Device class

Class II

Regulation

21 CFR 870.1210

Advisory committee

Cardiovascular

Statement or summary

Summary

Third party

Y

Location

Westminster, CO, US