510(k) Report

Devices descending from K082461

35 later devices reach Bare Platinum Framing Coil, Model (S)… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+1K093919Microplex Coil System-Cosmos Model 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-VMicroVention, Inc.201081
+1K090891Microplex Coil System-CosmosMicroVention, Inc.2009272
+1K090357Hydroframe (Hes)MicroVention, Inc.2009142
+2K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+2K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+2K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302
+2K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+2K102365Microplex Coil System- CosmosMicroVention, Inc.20103—
+2K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+2K093358Microplex Coil System-Cosmos, Models 81451CS-V, 181555CS-V, 16=81652CS-VMicroVention, Inc.201022—
+3K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+3K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+3K123338Barricade Embolization Coil SystemBlockade Medical201315—
+3K123384Azur CX Detachable 18MicroVention, Inc.20123—
+3K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+4K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+4K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+4K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+4K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+4K151760Barricade Embolization Coil SystemBlockade Medical201510—
+4K142513Barricade Embolization Coil SystemBlockade Medical201411—
+4K140104Barricade Embolization Coil SystemBlockade Medical201412—
+4K132482Barricade Embolization Coil SystemBlockade Medical201313—
+4K131475Barricade Embolization Coil SystemBlockade Medical201314—
+5K192068i-ED COILKaneka Pharma America, LLC20201—
+5K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+6K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+6K200030Optima Coil SystemBalt USA, LLC202065
+7K223386Optima Coil SystemBalt USA, LLC202231
+7K220699Prestige Coil SystemBait USA, LLC202212
+8K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+8K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+9K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+10K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—