Cleared Traditional

TriSalus TriNav? LV Infusion System

K230957 · Trisalus Life Sciences · Cardiovascular
May 2023
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K230957 is an FDA 510(k) clearance for the TriSalus TriNav? LV Infusion System, a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Trisalus Life Sciences (Westminster, US). The FDA issued a Cleared decision on May 2, 2023, 28 days after receiving the submission on April 4, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K230957 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2023
Decision Date May 02, 2023
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KRA — Catheter, Continuous Flush
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1210

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