510(k) Report

Devices descending from K191119

5 later devices reach EkoSonic Endovascular Device through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation202112
+1K211080EkoSonic Endovascular DeviceBoston Scientific20212—
+2K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…Thrombolex, Inc.20231—
+2K220866EKOS+ Endovascular DeviceBoston Scientific20220—
+3K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.20230—