510(k) Report

Devices descending from K925813

240 later devices reach Diagnostic Intravascular Catheter through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+5K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+5K080901Lbi Embolectomy SystemLumen Biomedical, Inc.20086—
+5K082461Bare Platinum Framing Coil, Model (S)…MicroVention, Inc.200835—
+5K080666Hydrosoft and Hydrosoft Plus Embolization Coil SystemsMicroVention, Inc.200834—
+5K080437Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFMicrus Endovascular Corporation200810—
+5K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+5K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+5K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+5K072526Micrus Courier Enzo Microcatheter 0.0190Micrus Endovascular Corporation20075—
+5K071762Omniwave Endovascular SystemOmnisonics Medical Technologies20071—
+5K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+5K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+5K062275Rinspiration Catheter System, Models 50135, 550135, P7065, P70135Kerberos Proximal Solutions, Inc.20069—
+5K053160Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation200535—
+6K231179Slinky CatheterAnoxia Medical, Inc.20230—
+6K230775SOFIA EX Intracranial Support CatheterMicroVention, Inc.20231—
+6K214024SOFIA 88 CatheterMicroVention, Inc.20220—
+6K213314CerusEndo Microcatheter (027)Cerus Endovascular, Inc.20220—
+6K211110Agile Devices Angler Steerable, Deflectable MicrocatheterAgile Devices, Inc.20220—
+6K211525SwiftNINJA Steerable MicrocatheterMerit Medical Systems, Inc.20210—
+6K201682RIST Radial Access CatheterRist Neurovascular, Inc.20202—
+6K192068i-ED COILKaneka Pharma America, LLC20201—
+6K192625PG Pro MicrocatheterMicroVention, Inc. A TERUMO Group Company20193—
+6K190126Bendit2.7 Steerable MicrocatheterBend IT Technologies, Ltd.20192—
+6K180904Sniper Infusion Catheter with Balloon OcclusionEmbolx, Inc.20180—
+6K172716V2K Rinspiration SystemV2k Medical, Inc.20180—
+6K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+6K151760Barricade Embolization Coil SystemBlockade Medical201510—
+6K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+6K143218Penumbra Smart CoilPenumbra, Inc.20154—
+6K140296Clearlumen Thrombectomy SystemWalk Vascular, LLC20142—
+6K142513Barricade Embolization Coil SystemBlockade Medical201411—
+6K141134Pod SystemPenumbra, Inc.20141—
+6K140104Barricade Embolization Coil SystemBlockade Medical201412—
+6K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+6K132482Barricade Embolization Coil SystemBlockade Medical201313—
+6K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+6K131475Barricade Embolization Coil SystemBlockade Medical201314—
+6K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+6K123377Target Detachable CoilStryker Neurovascular201212—
+6K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+6K123384Azur CX Detachable 18MicroVention, Inc.20123—
+6K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+6K120816Inzone Detachment SystemStryker20129—
+6K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+6K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+6K120630Azur Detachable 18MicroVention, Inc.201243
+6K113757Aspire Max Aspiration CatheterControl Medical Technology, LLC20125—
+6K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+6K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+6K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+6K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+6K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+6K090357Hydroframe (Hes)MicroVention, Inc.2009142
+6K083335Modified Omniwave Endovascular SystemOmnisonics Medical Technologies20080—
+6K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+6K071826The Rinspirator, Models FG09770, FG08776, FG08777, FG08910Fox Hollow Technologies20070—
+7K254046BosCATH Support CatheterSonorous NV, Inc.20260—
+7K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist…Micro Therapeutics, Inc. d/b/a ev3 Neurovascular20251—
+7K231600SENDERO MicrocatheterOkami Medical, Inc.20232—
+7K220780ROVO Mechanical Thrombectomy Device2mg, Inc.20231—
+7K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+7K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+7K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+7K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+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—
+7K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+7K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+7K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+7K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+7K170852POD Packing CoilPenumbra, Inc.20170—
+7K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+7K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+7K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+7K161786ClearLumen II Thrombectomy SystemWalk Vascular, LLC20161—
+7K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+7K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+7K153658Target Detachable CoilsStryker Neurovascular20161128
+7K160832Penumbra Smart CoilPenumbra, Inc.20162—
+7K160096InZone Detachment SystemStryker Neurovascular20168—
+7K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+7K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+7K151572Penumbra Smart CoilPenumbra, Inc.20153—
+7K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+7K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+7K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+7K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+7K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+7K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+7K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+7K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+7K122316Azur Detachable 35MicroVention, Inc.20120—
+7K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+7K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+7K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+7K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+7K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+8K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—