TriSalus Infusion System— 510(k) K193107

Name: FDA 510(k) clearance K193107
Creator: U.S. Food and Drug Administration
Published: 2019-12-03

Substantially Equivalent

Trisalus Life Sciences

FDA 510(k) clearance K193107 for TriSalus Infusion System, Substantially Equivalent on 2019-12-03. Applicant: Trisalus Life Sciences. Device class: 2.

Clearance details

Applicant: Trisalus Life Sciences
Product code: Code KRA
Device class: Class 2
Regulation: 21 CFR 870.1210
Advisory panel: Cardiovascular
Date received: 2019-11-08
Decision date: 2019-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westminster, CO, US

Download summary PDF View on FDA.gov ↗

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K250794 — InVera Infusion Device2026-03-12
K243534 — Micro Catheter2025-07-30

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Adverse events under product code KRA

product code KRA

Death: 234
Injury: 1,029
Malfunction: 3,012
Other: 2
Total: 4,277

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.