510(k) Report

Devices descending from K030637

50 later devices reach Ekos Peripheral Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+1K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+1K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+2K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+2K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+2K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+2K041629Lysus Infusion SystemEkos Corp.200439—
+3K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+3K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+3K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+3K050472Lysus Infusion SystemEkos Corp.20050—
+3K042456Lysus Infusion SystemEkos Corp.2004383
+4K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+4K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+4K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+4K062507Micro-Infusion SystemEkos Corp.200613—
+4K051319Lysus Infusion SystemEkos Corp.200535—
+4K043269Lysus Infusion SystemEkos Corp.20040—
+5K080392EndoWave Infusion SystemEkos Corp.200811—
+5K073166Endowave Infusion SystemEkos Corp.200811—
+5K052071Lysus Infusion SystemEkos Corp.200534—
+6K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+6K060422Lysus Infusion SystemEkos Corp.2006271
+6K060084Lysus Infusion SystemEkos Corp.200617—
+7K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+7K111705Ekosonic Endovascular SystemEkos Corporation201195
+7K072507Endowave Infusion SystemEkos Corp.2007133
+7K071933Endowave Infusion SystemEkos Corp.200712—
+8K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+8K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+8K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+9K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+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—
+9K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+9K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+10K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+10K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+10K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+10K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+10K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+11K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—
+11K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+11K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+11K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+11K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+12K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—