510(k) Report

Devices descending from K961923

203 later devices reach Berenstein Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+12K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+12K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+13K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—