K-number	K230957
Device name	TriSalus TriNav® LV Infusion System
Applicant	Trisalus Life Sciences
Product code	KRA
Device class	Class II
Decision date	May 2, 2023
Decision	Substantially Equivalent
Regulation	870.1210

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Source

View the full FDA submission: accessdata.fda.gov

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TriSalus TriNav® LV Infusion System

Everything you need for a 510(k) submission. Nothing you don't.