FDA 510(k)

TriSalus Infusion System

K-Number: K193107 · 2019-12-03

Decision Date2019-12-03

Product CodeKRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

TriSalus Infusion System is a medical device manufactured by Trisalus Life Sciences. It received FDA 510(k) clearance on 2019-12-03 under approval number K193107. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TriSalus Infusion System?

TriSalus Infusion System is a medical device that received FDA 510(k) clearance on 2019-12-03. It is manufactured by Trisalus Life Sciences. The 510(k) number is K193107.

When was TriSalus Infusion System approved by the FDA?

TriSalus Infusion System received FDA 510(k) clearance on 2019-12-03, under approval number K193107.

What company makes TriSalus Infusion System?

TriSalus Infusion System is manufactured by Trisalus Life Sciences.

What is the FDA product code for TriSalus Infusion System?

The FDA product code for TriSalus Infusion System is KRA.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.