510(k) Report

Devices descending from K961763

104 later devices reach Pulse*Spray Infusion System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K163356Pulse* Spray Infusion System, Uni*Fuse Infusion SystemAngioDynamics, Inc.201701
+1K123235Equaflow Multivalve Infusion CatheterCook Incorporated20130—
+1K974067Fountain Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199810123
+2K193082Fountain ValveTip Infusion CatheterMerit Medical Systems, Inc.20200—
+2K041629Lysus Infusion SystemEkos Corp.200439—
+2K031485Rinspiration SystemKerberos Proximal Solutions200319—
+2K992231FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.1999402
+2K991619FOUNTAIN Infusion Catheter and Occluding Guide WireMerit Medical Systems, Inc.199943—
+2K981417Squirt Fluid Delivery SystemMerit Medical Systems, Inc.199895—
+3K182071Multi-Sideport Catheter Infusion SetCook Incorporated20190—
+3K162777Squirt Fluid Delivery SystemMerit Medical Systems, Inc.20160—
+3K050472Lysus Infusion SystemEkos Corp.20050—
+3K042456Lysus Infusion SystemEkos Corp.2004383
+3K041123Rinspiration System,Rinspiration System Short Tip, Models FG01477/FG01703Kerberos Proximal Solutions, Inc.200417—
+3K041291Rinspiration SystemKerberos Proximal Solutions, Inc.200417—
+3K024190Fenestrated Infusion CatheterPromedic, Inc.20030—
+3K013635Trellis Infusion System (10CM Infusion Length); Trellis Infusion System (20CM Infusion…Bacchus Vascular, Inc.200275—
+4K141617Cleaner Rotational Thrombectomy SystemRex Medical, L.P.20147—
+4K071468Clarivein CatheterVascular Insights, LLC200841
+4K051319Lysus Infusion SystemEkos Corp.200535—
+4K050130Kerberos Proximal Solutions Rispiration SystemKerberos Proximal Solutions, Inc.200516—
+4K043269Lysus Infusion SystemEkos Corp.20040—
+4K041517InfusioncathId, LLC20043—
+4K023514Trellis-6 Peripheral Infusion System (140CM Catheter Length 10CM Infusion Length)Bacchus Vascular, Inc.2002561
+4K021958Trellis Plus Infusion System (140CM Catheter Length 10CM Infusion Length 20CM (100CM…Bacchus Vascular, Inc.2002571
+5K211798Cleaner Plus Thrombectomy SystemArgon Medical Devices, Inc.20225—
+5K201705ReVene Thrombectomy CatheterVetex Medical, Ltd.20200—
+5K153502ClariVein ICVascular Insights, LLC20163—
+5K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+5K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+5K073400Varicath Peripheral Infusion CatheterVeinrx, Inc.20070—
+5K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+5K052844Kavs - Catheter, Models 1107100 & 1107060Richter & Rothe AG20060—
+5K052738Infusioncath Peripheral Infusion Catheter, Models VF0012, VF0016, VF0024, VF0028…Veinrx, Inc.20051—
+5K052071Lysus Infusion SystemEkos Corp.200534—
+5K032261Trellis Reserve Infusion SystemBacchus Vascular, Inc.20036—
+5K030637Ekos Peripheral Infusion SystemEkos Corp.200350—
+6K233909Cleaner™ Plus 18F Thrombectomy System - Cleaner™ Plus 18F Aspiration Catheter, Cleaner™…Argon Medical Devices, Inc.20240—
+6K223176Cleaner Plus™ Thrombectomy System, Cleaner Plus™ Aspiration Catheter, Cleaner Plus™…Argon Medical Devices, Inc.20230—
+6K223891Cobra Catheter SystemEndovascular Engineering20232—
+6K201907ClariVein ICMerit Medical Systems, Inc.20202—
+6K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+6K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+6K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+6K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+6K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+6K060422Lysus Infusion SystemEkos Corp.2006271
+6K060084Lysus Infusion SystemEkos Corp.200617—
+6K041826Ekos Ultrasound Infusion SystemEkos Corp.200519—
+6K050147Trellis-8 Peripheral Infusion SystemBacchus Vascular, Inc.20055—
+6K033569Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer SheathFlowmedica, Inc.200412
+6K033214Ekos Peripheral Infusion SystemEkos Corp.200346—
+7K250794InVera Infusion DeviceInvera Medical20260—
+7K252956Helo Thrombectomy SystemEndovascular Engineering, Inc.20251—
+7K231148ScleroSafe™ 150 mm, ScleroSafe™ 350 mmVvt Medical, Ltd.20230—
+7K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+7K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+7K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+7K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+7K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+7K130904Trellis-8 Peripheral Infusion SystemCovidien20130Class I
+7K082163Flowmedica Benephit Infusion SystemsFlowmedica, Inc.200806
+7K072507Endowave Infusion SystemEkos Corp.2007133
+7K071933Endowave Infusion SystemEkos Corp.200712—
+7K071664Trellis-6 Peripheral Infusion SystemBacchus Vascular, Inc.20071Class I
+7K062508Neurowave Micro-Infusion SystemEkos Corp.200614—
+7K062507Micro-Infusion SystemEkos Corp.200613—
+7K051225Ekos Micro-Infusion SystemEkos Corp.200518—
+7K050563Ekos Peripheral Infusion SystemEkos Corp.200521—
+8K261800Helo Max Thrombectomy System (HEL2090)Endovascular Engineering20260—
+8K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+8K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+8K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+8K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+8K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+8K082199Spiralfuse Peripheral Infusion SystemBacchus Vascular, Inc.20080—
+8K080392EndoWave Infusion SystemEkos Corp.200811—
+8K073166Endowave Infusion SystemEkos Corp.200811—
+8K063620Ekos Micro-Infusion SystemEkos Corp.200712—
+8K053437Ekos Micro-Infusion SystemEkos Corp.200616—
+8K053432Ekos Micro-Infusion SystemEkos Corp.200516—
+9K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+9K180958Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular…Shockwave Medical, Inc.20184—
+9K180454Shockwave Medical Intravascular Lithotripsy (IVL) SystemShockwave Medical, Inc.201841
+9K081467Ekosonic Endovascular System with Rapid Pulse ModulationEkos Corp.2008105
+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—
+10K191840Peripheral Intravascular Lithotripsy (IVL) Catheters, IVL Generator and Connector Cable…Shockwave Medical, Inc.20193—
+10K111705Ekosonic Endovascular SystemEkos Corporation201195
+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—
+11K183290Bashir Endovascular Catheter Model 7201, Bashir N-X Endovascular Catheter, Mode 7200Thrombolex, Inc.20198—
+12K262201Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave E8 Peripheral IVL…Shockwave Medical, Inc.20260—
+12K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+12K211061BASHIR Endovascular Catheter (Ref. 7201), BASHIR Plus 10 Endovascular Catheter (Ref.…Thrombolex, Inc.20210—
+12K192864UNI*FUSE Infusion System with Cooper WireAngioDynamics, Inc.20202—
+12K193071Bashir Plus Endovascular CatheterThrombolex, Inc.20191—