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FDA 510(k)

TriSalus TriNav® LV Infusion System

K-Number: K230957 · 2023-05-02

ApplicantTrisalus Life Sciences
Decision Date2023-05-02
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TriSalus TriNav® LV Infusion System is a medical device manufactured by Trisalus Life Sciences. It received FDA 510(k) clearance on 2023-05-02 under approval number K230957. 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 TriNav® LV Infusion System?

TriSalus TriNav® LV Infusion System is a medical device that received FDA 510(k) clearance on 2023-05-02. It is manufactured by Trisalus Life Sciences. The 510(k) number is K230957.

When was TriSalus TriNav® LV Infusion System approved by the FDA?

TriSalus TriNav® LV Infusion System received FDA 510(k) clearance on 2023-05-02, under approval number K230957.

What company makes TriSalus TriNav® LV Infusion System?

TriSalus TriNav® LV Infusion System is manufactured by Trisalus Life Sciences.

What is the FDA product code for TriSalus TriNav® LV Infusion System?

The FDA product code for TriSalus TriNav® LV Infusion System is KRA.

Related Clinical Trials

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Other Devices by Trisalus Life Sciences

K193107TriSalus Infusion System K233858TriSalus TriGuideTM Guiding Catheter

Related Devices (Code: KRA)

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Official Source

View on FDA Database →

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

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