Cleared Traditional

TriSalus Infusion System

K193107 · Trisalus Life Sciences · Cardiovascular
Dec 2019
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K193107 is an FDA 510(k) clearance for the TriSalus 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 December 3, 2019, 25 days after receiving the submission on November 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number K193107 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2019
Decision Date December 03, 2019
Days to Decision 25 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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