510(k) Report

Devices descending from K153658

11 later devices reach Target Detachable Coils through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K242243Target Detachable CoilsStryker Neurovscular20242—
+1K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+1K161429Target Detachable CoilsStryker Neurovascular201610—
+2K252694Target Detachable CoilStryker Neurovascular20251—
+2K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+2K192068i-ED COILKaneka Pharma America, LLC20201—
+3K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+3K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+3K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+4K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+5K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—