510(k) Report

Devices descending from K091641

23 later devices reach Hydrocoil Embolic System (Hydrosoft) and Microplex Coil System (Hypersoft) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+1K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+1K112226Hydrocoil Embolic System (Hes)MicroVention, Inc.201121—
+2K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+2K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+2K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+3K123338Barricade Embolization Coil SystemBlockade Medical201315—
+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—