510(k) Report

Devices descending from K180677

2 later devices reach Surefire Spark Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+2K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—