510(k) Report

Devices descending from K113412

13 later devices reach Target Detachable Coil through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123377Target Detachable CoilStryker Neurovascular201212—
+2K153658Target Detachable CoilsStryker Neurovascular20161128
+3K242243Target Detachable CoilsStryker Neurovscular20242—
+3K222533Target Tetra Detachable CoilsStryker Neurovascular20223—
+3K161429Target Detachable CoilsStryker Neurovascular201610—
+4K252694Target Detachable CoilStryker Neurovascular20251—
+4K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+4K192068i-ED COILKaneka Pharma America, LLC20201—
+5K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+5K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+5K210638i-ED COIL SystemKaneka Medical America, LLC20210—
+6K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+7K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—