510(k) Report

Devices descending from K002533

32 later devices reach TCD 100M, PWD13 Transducer through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K160442Lucid M1 Transcranial Doppler Ultrasound System (Lucid M1 System) with 2MHz TransducersNeural Analytics, Inc.201622
+1K123565Presto 1000 SystemPhysiosonics, Inc.20120—
+1K110752Highland Instruments Ces and Tus Instrument HolderHighland Instruments20110—
+1K092204PMD ViewerSpencer Technologies20090—
+1K060421Sonara; Sonara/TekViasys Healthcare, Inc.200632
+1K051085Doppler-BoxCompumedics Germany Gmgh20055—
+1K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+2K180455NeuralBotNeural Analytics, Inc.201811
+2K170859Dolphin/IQ and Dolphin/4DViasonix, Ltd.20172—
+2K141462Varia-NciNeurochaos Solutions, Inc.20140—
+2K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+3K213279NovaGuide 2 Intelligent UltrasoundNovasignal Corporation202202
+3K191023Dolphin/IQ, Dolphin/4D and Dolphin/MAXViasonix, Ltd.20191—
+3K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+3K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+4K202742Dolphin/IQ, Dolphin/4D and Dolphin/MAX with Dolphin/XF robot accessoryViasonix, Ltd.20210—
+4K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+4K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+4K062507Micro-Infusion SystemEkos Corp.200613—
+5K080392EndoWave Infusion SystemEkos Corp.200811—
+5K073166Endowave Infusion SystemEkos Corp.200811—
+6K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+7K111705Ekosonic Endovascular SystemEkos Corporation201195
+8K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+9K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+9K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+9K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+9K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+9K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+10K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+10K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+11K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—