510(k) Report

Devices descending from K103355

16 later devices reach GDC 360 Deteachable Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123338Barricade Embolization Coil SystemBlockade Medical201315—
+2K151760Barricade Embolization Coil SystemBlockade Medical201510—
+2K142513Barricade Embolization Coil SystemBlockade Medical201411—
+2K140104Barricade Embolization Coil SystemBlockade Medical201412—
+2K132482Barricade Embolization Coil SystemBlockade Medical201313—
+2K131475Barricade Embolization Coil SystemBlockade Medical201314—
+3K192068i-ED COILKaneka Pharma America, LLC20201—
+3K172390Optima Coil SystemBlockade Medical, LLC (D.B.A. Balt Usa)201874
+4K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K200030Optima Coil SystemBalt USA, LLC202065
+5K223386Optima Coil SystemBalt USA, LLC202231
+5K220699Prestige Coil SystemBait USA, LLC202212
+6K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+6K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+7K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+8K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—