510(k) Report

Devices descending from K162771

8 later devices reach EkoSonic Endovascular System with Control Unit 4.0 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K183361EkoSonic Endovascular Device with Control Unit 4.0Btg International, Inc.201972
+2K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)Ekos Corporation202021
+2K191119EkoSonic Endovascular DeviceBtg International, Inc.20195—
+3K213422EkoSonic Endovascular Device, EKOS+ Endovascular DeviceBoston Scientific Corporation202112
+3K211080EkoSonic Endovascular DeviceBoston Scientific20212—
+4K222095BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No.…Thrombolex, Inc.20231—
+4K220866EKOS+ Endovascular DeviceBoston Scientific20220—
+5K231653BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.20230—