510(k) Report

Devices descending from K002056

106 later devices reach Micrus Microcoil Delivery System, MDS03 through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K223386Optima Coil SystemBalt USA, LLC202231
+12K220699Prestige Coil SystemBait USA, LLC202212
+13K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+13K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+14K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+15K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—