Class Class II
TriSalus TriNav® LV Infusion System (K230957)
Description
TriSalus TriNav® LV Infusion System by Trisalus Life Sciences, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK230957
Clearance Date2023-05-02
Clearance TypeTraditional
Product CodeKRA
Regulation Number870.1210
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230957
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. TriSalus TriNav® LV Infusion System (K230957) cites 2 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K180677 | Surefire Spark Infusion System | Surefire Medical, Inc. | 2018 |
| K160662 | Surefire Infusion System | Surefire Medical, Inc. | 2016 |
Trace the full predicate network for K230957
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.