510(k) Report

Devices descending from K200648

2 later devices reach EKOS PE Endovascular Device with Control System 4.0 (CS4.0) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation202112
+2K220866EKOS+ Endovascular DeviceBoston Scientific20220—