510(k) Report

Devices descending from K112226

21 later devices reach Hydrocoil Embolic System (Hes) through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+1K120908Hydrocoil Embolic System (Hes)MicroVention, Inc.201219—
+1K113457Hydrocoil Embolic System (Hes)MicroVention, Inc.201120—
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+2K123338Barricade Embolization Coil SystemBlockade Medical201315—
+3K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+3K151760Barricade Embolization Coil SystemBlockade Medical201510—
+3K142513Barricade Embolization Coil SystemBlockade Medical201411—
+3K140104Barricade Embolization Coil SystemBlockade Medical201412—
+3K132482Barricade Embolization Coil SystemBlockade Medical201313—
+3K131475Barricade Embolization Coil SystemBlockade Medical201314—
+4K192068i-ED COILKaneka Pharma America, LLC20201—
+4K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+5K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+5K200030Optima Coil SystemBalt USA, LLC202065
+6K223386Optima Coil SystemBalt USA, LLC202231
+6K220699Prestige Coil SystemBait USA, LLC202212
+7K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+7K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+8K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+9K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—