510(k) Report

Devices descending from K041629

39 later devices reach Lysus Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K050472Lysus Infusion SystemEkos Corp.20050—
+1K042456Lysus Infusion SystemEkos Corp.2004383
+2K051319Lysus Infusion SystemEkos Corp.200535—
+2K043269Lysus Infusion SystemEkos Corp.20040—
+3K052071Lysus Infusion SystemEkos Corp.200534—
+4K060422Lysus Infusion SystemEkos Corp.2006271
+4K060084Lysus Infusion SystemEkos Corp.200617—
+5K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+5K072507Endowave Infusion SystemEkos Corp.2007133
+5K071933Endowave Infusion SystemEkos Corp.200712—
+5K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+5K062507Micro-Infusion SystemEkos Corp.200613—
+6K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+6K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+6K080392EndoWave Infusion SystemEkos Corp.200811—
+6K073166Endowave Infusion SystemEkos Corp.200811—
+6K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+7K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+7K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+7K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+7K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+8K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+8K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+8K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+8K111705Ekosonic Endovascular SystemEkos Corporation201195
+9K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+9K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+9K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+9K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+9K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+10K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—
+10K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+10K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+10K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+10K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+10K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+11K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+11K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+12K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—