510(k) Report

Devices descending from K161402

4 later devices reach Bullfrog Micro-Infusion Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K222185Stratus Infusion CatheterIntervene, Inc.20230—
+1K213442Extroducer Infusion Catheter SystemSmartWise Sweden AB20221—
+1K210339Bullfrog Micro-Infusion DeviceMercator Medsystems, Inc.20210—
+2K254051Extroducer Infusion Catheter SystemSmartWise Sweden AB20260—