510(k) Report

Devices descending from K121677

7 later devices reach Surefire HI-Flow Microcatheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K143588Surefire Infusion System 021Surefire Medical, Inc.20156—
+2K171355Surefire Precision Infusion SystemSurefire Medical, Inc.20174—
+2K160662Surefire Infusion SystemSurefire Medical, Inc.20165—
+3K193107TriSalus Infusion SystemTrisalus Life Sciences20190—
+3K180677Surefire Spark Infusion SystemSurefire Medical, Inc.20182—
+4K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+5K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—