510(k) Report

Devices descending from K926243

58 later devices reach Angiographic Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+1K030637Ekos Peripheral Infusion SystemEkos Corp.200350—
+1K993292Boston Scientific/Target Sentry Occlusion Balloon CatheterBoston Scientific, Target20006—
+2K080861Micrus Ascent Occlusion Balloon CatheterMicrus Endovascular Corporation20084—
+2K073166Endowave Infusion SystemEkos Corp.200811—
+2K070126Occlusion Balloon CatheterSentreheart, Inc.20080—
+2K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+2K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+2K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+3K091504Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…Micrus Endovascular Corporation20093—
+3K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+3K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+3K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+3K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+3K041629Lysus Infusion SystemEkos Corp.200439—
+4K111705Ekosonic Endovascular SystemEkos Corporation201195
+4K103780Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…Micrus Endovascular Corporation20112—
+4K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+4K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+4K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+4K050472Lysus Infusion SystemEkos Corp.20050—
+4K042456Lysus Infusion SystemEkos Corp.2004383
+5K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+5K142692Occlusion Balloon CatheterEmbolx, Inc.20151—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+5K062507Micro-Infusion SystemEkos Corp.200613—
+5K051319Lysus Infusion SystemEkos Corp.200535—
+5K043269Lysus Infusion SystemEkos Corp.20040—
+6K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+6K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+6K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+6K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—
+6K192598Bashir S-B Endovascular Catheter, Ref. No. 7101Thrombolex, Inc.20190—
+6K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.20180—
+6K080392EndoWave Infusion SystemEkos Corp.200811—
+6K052071Lysus Infusion SystemEkos Corp.200534—
+7K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+7K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+7K060422Lysus Infusion SystemEkos Corp.2006271
+7K060084Lysus Infusion SystemEkos Corp.200617—
+8K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—
+8K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+8K072507Endowave Infusion SystemEkos Corp.2007133
+8K071933Endowave Infusion SystemEkos Corp.200712—
+9K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+9K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+10K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+10K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+10K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+11K221852Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20221—
+11K203365Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL…Shockwave Medical, Inc.20211—
+11K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+12K242213Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral…Shockwave Medical, Inc.20240—
+12K240954Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave L6 Peripheral IVL…Shockwave Medical, Inc.20240—
+12K240225Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20241—
+12K221041Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.20220—
+13K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—