510(k) Report

Devices descending from K961923

203 later devices reach Berenstein Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+6K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+6K071939Hydrocoil Embolic Systems (Hes)MicroVention, Inc.200823—
+6K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+6K071246Micrus Microcoil Delivery System, Models SPH, Hel, Che, PC4, HSR, FSR, CSP, CFS, SRC…Micrus Endovascular Corporation20070—
+6K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+6K053160Micrus Modified Microcoil 18-System, Cerecyte, Model CSP & CheMicrus Endovascular Corporation200535—
+7K261488OBSIDIO Conformable EmbolicBoston Scientific Corporation20260—
+7K253376OBSIDIO™ Conformable Embolic (M0013972101010)Boston Scientific Corporation20250—
+7K192068i-ED COILKaneka Pharma America, LLC20201—
+7K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+7K151760Barricade Embolization Coil SystemBlockade Medical201510—
+7K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+7K143218Penumbra Smart CoilPenumbra, Inc.20154—
+7K142513Barricade Embolization Coil SystemBlockade Medical201411—
+7K141134Pod SystemPenumbra, Inc.20141—
+7K140104Barricade Embolization Coil SystemBlockade Medical201412—
+7K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+7K132482Barricade Embolization Coil SystemBlockade Medical201313—
+7K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+7K131475Barricade Embolization Coil SystemBlockade Medical201314—
+7K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+7K123377Target Detachable CoilStryker Neurovascular201212—
+7K122543Azur Pure Peripheral Coil System, Pushable 18 Azur Pure Peripheral Coil System, Pushable…MicroVention, Inc.20122—
+7K123384Azur CX Detachable 18MicroVention, Inc.20123—
+7K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+7K120816Inzone Detachment SystemStryker20129—
+7K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+7K120330Penumbra Coil System/Penumbra Coil 400Penumbra, Inc.20129—
+7K120630Azur Detachable 18MicroVention, Inc.201243
+7K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+7K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+7K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+7K093002Azur Peripheral Hydrocoil Endovascular Embolization System-Detachable 35, Models…MicroVention, Inc.200912—
+7K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+7K090357Hydroframe (Hes)MicroVention, Inc.2009142
+7K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+8K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+8K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+8K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+8K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+8K192955Penumbra LP Coil SystemPenumbra, Inc.20191—
+8K173614Penumbra Coil 400, Ruby Coil System, POD SystemPenumbra, Inc.20181—
+8K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+8K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+8K170852POD Packing CoilPenumbra, Inc.20170—
+8K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+8K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+8K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+8K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+8K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+8K153658Target Detachable CoilsStryker Neurovascular20161128
+8K160832Penumbra Smart CoilPenumbra, Inc.20162—
+8K160096InZone Detachment SystemStryker Neurovascular20168—
+8K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+8K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+8K151572Penumbra Smart CoilPenumbra, Inc.20153—
+8K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+8K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+8K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+8K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+8K133626Azur Pure Peripheral Coil System, Pushable 35MicroVention, Inc.20130—
+8K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+8K132083Azur Pure Peripheral Coil Systems, Pushable 35MicroVention, Inc.20130—
+8K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+8K122316Azur Detachable 35MicroVention, Inc.20120—
+8K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+8K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+8K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+8K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+8K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+9K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+9K250079Ruby XL SystemPenumbra, Inc.20250—
+9K242243Target Detachable CoilsStryker Neurovscular20242—
+9K230284Penumbra LP Coil SystemPenumbra, Inc.20230—
+9K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+9K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+9K212455InZone Detachment SystemStryker Neurovascular202111
+9K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+9K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+9K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+9K191680AZUR Vascular PlugMicroVention, Inc.20200—
+9K200030Optima Coil SystemBalt USA, LLC202065
+9K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+9K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+9K161429Target Detachable CoilsStryker Neurovascular201610—
+9K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+9K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+10K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+10K252694Target Detachable CoilStryker Neurovascular20251—
+10K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+10K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+10K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+10K223386Optima Coil SystemBalt USA, LLC202231
+10K220699Prestige Coil SystemBait USA, LLC202212
+10K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+11K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+11K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+11K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+11K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+11K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—