510(k) Report

Devices descending from K051225

18 later devices reach Ekos Micro-Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+1K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+2K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+2K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+2K062507Micro-Infusion SystemEkos Corp.200613—
+3K080392EndoWave Infusion SystemEkos Corp.200811—
+3K073166Endowave Infusion SystemEkos Corp.200811—
+4K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+5K111705Ekosonic Endovascular SystemEkos Corporation201195
+6K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+7K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+7K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+7K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+7K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+7K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+8K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+8K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+9K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—