510(k) Report

Devices descending from K930738

231 later devices reach Surgical Sutures, PGL, Gut, Deklene, Opthamend Etc through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K212455InZone Detachment SystemStryker Neurovascular202111
+7K203625Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20213—
+7K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+7K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K200030Optima Coil SystemBalt USA, LLC202065
+7K191466SandShark Injectable Anchor (SIA) SystemStimwave Technologies, Inc.20190—
+7K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+7K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+7K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+7K161429Target Detachable CoilsStryker Neurovascular201610—
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+7K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+8K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+8K252694Target Detachable CoilStryker Neurovascular20251—
+8K251832InZone IST Detachment System; IZDS Connecting CableStryker Neurovascular20250—
+8K232955Numen Coil Embolization System; NumenFR Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20242—
+8K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+8K223386Optima Coil SystemBalt USA, LLC202231
+8K220699Prestige Coil SystemBait USA, LLC202212
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+8K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—
+9K261772Target Xtra Detachable CoilStryker Neurovscular20260—
+9K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+9K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+9K242154Numen™ Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20241—
+9K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+10K260351Numen™ Helia Coil Embolization System; NumenFR™ Detachment SystemMicroPort NeuroTech (Shanghai) Co., Ltd.20260—
+10K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+11K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—