510(k) Report

Devices descending from K160662

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K171355Surefire Precision Infusion SystemSurefire Medical, Inc.20174—
+2K193107TriSalus Infusion SystemTrisalus Life Sciences20190—
+2K180677Surefire Spark Infusion SystemSurefire Medical, Inc.20182—
+3K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+4K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—