510(k) Report

Devices descending from K960806

186 later devices reach Turbo Tracker through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K120508Clearlumen Thrombectomy SystemWalk Vascular, LLC20123—
+5K110813Headway 27 MicrocatheterMicroVention, Inc.20118—
+5K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+5K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+5K080392EndoWave Infusion SystemEkos Corp.200811—
+5K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation20075—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+5K051319Lysus Infusion SystemEkos Corp.200535—
+5K043269Lysus Infusion SystemEkos Corp.20040—
+6K252213Bendit17 MicrocatheterBend IT Technologies, Ltd.20250—
+6K252569Carrier XL Delivery CatheterBalt USA, LLC20250—
+6K241851Versus™ Catheter (VS110-8B)Liquet Medical, Inc.20241—
+6K231608Teleport XT MicrocatheterOrbusNeich Medical (Shenzhen) Co., Ltd.20241—
+6K220647GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…Vascular Solutions, LLC20220—
+6K213065Distal Access CatheterGuangzhou Easycess Medical Co.,Ltd20220—
+6K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.20220—
+6K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.20210—
+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—
+6K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20192—
+6K182602SOFIA EX Intracranial Support CatheterMicroVention, Inc.20192—
+6K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.20180—
+6K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+6K173560MicrocatheterSurmodics,Inc.20181—
+6K173662speX Support CatheterReflow Medical, Inc.20175—
+6K161362ASAHI Corsair ArmetAsahi Intecc Co., Ltd.20162—
+6K151082MicroCross CatheterRoxwood Medical, Inc.20150—
+6K150366SOFIA 6F CatheterMicroVention, Inc.20156—
+6K142449Headway 27 MicrocatheterMicroVention, Inc.20155—
+6K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+6K142014Sofia Distal Access CatheterMicroVention, Inc.20147—
+6K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+6K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+6K052071Lysus Infusion SystemEkos Corp.200534—
+7K260149Versus™ Catheter (VS110-9NB)Liquet Medical, Inc.20260—
+7K242588COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL)OrbusNeich Medical (Shenzhen) Co., Ltd.20250—
+7K231179Slinky CatheterAnoxia Medical, Inc.20230—
+7K232647MicrocatheterSurmodics,Inc.20230—
+7K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+7K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+7K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+7K213314CerusEndo Microcatheter (027)Cerus Endovascular, Inc.20220—
+7K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+7K202347UNIFUSE Infusion System with Cooper WireAngioDynamics, Inc.20201—
+7K202252ASAHI Corsair Armet 18 Microcatheter (Model: CSAR060-18N), ASAHI Corsair Armet 18…Asahi Intecc Co., Ltd.20200—
+7K200582Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20201—
+7K200629Aspire Mechanical Aspirator GControl Medical Technology20200—
+7K200871Aspire MAX 7 - 11F Mechanical Thrombectomy System and Aspire Mechanical AspiratorControl Medical Technology20201—
+7K200094speX LP Support CatheterReflow Medical20201—
+7K193012speX Support CatheterReflow Medical20202—
+7K192782ASAHI CROSSWALK Peripheral Support CatheterAsahi Intecc Co., Ltd.20190—
+7K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company20193—
+7K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+7K060422Lysus Infusion SystemEkos Corp.2006271
+7K060084Lysus Infusion SystemEkos Corp.200617—
+8K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+8K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.20260—
+8K251318VariFuse Adjustable Infusion CatheterArgon Medical Devices, Inc.20260—
+8K250013VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…Control Medical Technology, Inc. / Dba Ventiv Scientific20250—
+8K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+8K233350SINC Support CatheterReflow Medical, Inc.20240—
+8K231600SENDERO MicrocatheterOkami Medical, Inc.20232—
+8K201811coraForce and coraFlex Support CathetersReflow Medical, Inc.20201—
+8K163051ClearLumen II Peripheral Thrombectomy SystemWalk Vascular, LLC20170—
+8K161384Lithoplasty Peripheral Balloon Dilatation Catheter, Lithoplasty Generator and Connector…Shockwave Medical, Inc.201613—
+8K072507Endowave Infusion SystemEkos Corp.2007133
+8K071933Endowave Infusion SystemEkos Corp.200712—
+9K254178SAYA 86 Radial Access Guide CatheterAsahi Intecc Co., Ltd.20260—
+9K251277CoraForce Microcatheter, CoraFlex MicrocatheterReflow Medical, Inc.20250—
+9K250225Bolt Intravascular Lithotripsy (IVL) SystemBolt Medical, Inc.20251—
+9K240384SENDERO MicrocatheterOkami Medical, Inc.20241—
+9K163306Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector…Shockwave Medical, Inc.201610—
+10K260246SEISMIQ™ Intravascular Lithotripsy SystemBolt Medical, Inc.20260—
+10K242644SENDERO MAX Delivery CatheterOkami Medical, Inc.20240—
+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—