510(k) Report

Devices descending from K033443

41 later devices reach Speedlyser Infusion Catheter Kit through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K170258SpeedLyser Infusion Catheter KitAngioDynamics, Inc.20170—
+1K041629Lysus Infusion SystemEkos Corp.200439—
+2K050472Lysus Infusion SystemEkos Corp.20050—
+2K042456Lysus Infusion SystemEkos Corp.2004383
+3K051319Lysus Infusion SystemEkos Corp.200535—
+3K043269Lysus Infusion SystemEkos Corp.20040—
+4K052071Lysus Infusion SystemEkos Corp.200534—
+5K060422Lysus Infusion SystemEkos Corp.2006271
+5K060084Lysus Infusion SystemEkos Corp.200617—
+6K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+6K072507Endowave Infusion SystemEkos Corp.2007133
+6K071933Endowave Infusion SystemEkos Corp.200712—
+6K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+6K062507Micro-Infusion SystemEkos Corp.200613—
+7K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+7K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+7K080392EndoWave Infusion SystemEkos Corp.200811—
+7K073166Endowave Infusion SystemEkos Corp.200811—
+7K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+8K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+8K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+8K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+8K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+9K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+9K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+9K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+9K111705Ekosonic Endovascular SystemEkos Corporation201195
+10K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+10K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+10K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+10K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+10K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+11K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—
+11K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+11K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+11K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+11K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+11K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+12K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+12K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+13K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—