510(k) Report

Devices descending from K062126

10 later devices reach Embocath Plus Infusion Microcatheter, Model Ecp-100 and Ecp-135 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K110459Surefire Infusion Catheter SystemSurefire Medical, Inc.20119—
+2K121677Surefire HI-Flow MicrocatheterSurefire Medical, Inc.20127—
+2K113737Surefire Guide SheathSurefire Medical, Inc.20120—
+3K143588Surefire Infusion System 021Surefire Medical, Inc.20156—
+4K171355Surefire Precision Infusion SystemSurefire Medical, Inc.20174—
+4K160662Surefire Infusion SystemSurefire Medical, Inc.20165—
+5K193107TriSalus Infusion SystemTrisalus Life Sciences20190—
+5K180677Surefire Spark Infusion SystemSurefire Medical, Inc.20182—
+6K230957TriSalus TriNav® LV Infusion SystemTrisalus Life Sciences20231—
+7K253509TriSalus TriNav Advance Infusion SystemTrisalus Life Sciences20260—