510(k) Report

Devices descending from K110459

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

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc.20127—
+1K113737Surefire Guide SheathSurefire Medical, Inc.20120—
+2K143588Surefire Infusion System 021Surefire Medical, Inc.20156—
+3K171355Surefire Precision Infusion SystemSurefire Medical, Inc.20174—
+3K160662Surefire Infusion SystemSurefire Medical, Inc.20165—
+4K193107TriSalus Infusion SystemTrisalus Life Sciences20190—
+4K180677Surefire Spark Infusion SystemSurefire Medical, Inc.20182—
+5K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+6K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—