510(k) Report

Devices descending from K032553

37 later devices reach Trufill DCS Orbit Detachable Coil and Trufill DCS Syringe, Also Known as… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K123560Vascular Occlusion System (Trufill Pushable Coils), and Trufill DCS Orbit Detachable…Codman & Shurtleff, Inc.20130—
+1K063653Micrus Microcoil System, Cashmere Model SRCMicrus Endovascular Corporation200735—
+2K072173Micrus Microcoil System Cashmere-Cerecyte, Model CRC; Cashmere-SR, Model SRCMicrus Endovascular Corporation200791
+2K070707Micrus Microcoil SystemMicrus Endovascular Corporation200732—
+3K142429CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2…Codman & Shurtleff, Inc.20140—
+3K120686Orbit Galaxy G2 Microcoil Delivery SystemCodman & Shurtleff, Inc.20121—
+3K082739Micrus Microcoil Delivery SystemMicrus Endovascular Corporation20087—
+3K073442Micrus Microcoil SystemsMicrus Endovascular Corporation200831—
+4K150319Micrusframe 10/18, Deltafill 18, Deltaxsft 10, Galaxy G3 Fill/XSFT Stretch Resistant…Codman & Shurtleff, Inc.20155—
+4K081465Axium Detachable Coil SystemMicro Therapeutics, Inc.2008222
+5K220040CEREPAK Uniform, Uniform XL, Uniform 3D, Heliform Soft, Heliform XtraSoft, Heliform XL…Medos International SARL20220Class I
+5K211344MICRUSFRAME, DELTAFILL, DELTAXSFT, GALAXY G3, GALAXY G3 XSFT, and GALAXY G3 Mini…Medos International SARL20211—
+5K171862GALAXY G3 Mini Microcoil Delivery SystemCodman & Shurtleff, Inc.201721
+5K171747MICRUSFRAME 10 Stretch Resistant Microcoil Delivery System, MICRUSFRAME 18 Stretch…Codman & Shurtleff, Inc.20172—
+5K162704Axium Prime Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20174—
+5K151447Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20155—
+5K133310Axium Detachable Coil SystemMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20146—
+5K123803Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation201310—
+5K090046Concerto Detachable Coil SystemMicro Therapeutics, Inc.20093—
+6K262419Micrusframe (MFR100202); Micrusframe (MFR100253); Micrusframe (MFR100305); Micrusframe…Cerenovus, Inc.20260—
+6K203432Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular202111
+6K202850Concerto Versa, Detachable CoilMicro Therapeutics, Inc. d/b/a ev3 Neurovascular20212—
+6K180653Spartan eCoil SystemSpartan Micro, Inc.20180—
+6K173711Wallaby Avenir Coil SystemWallaby Medical, Inc.20180—
+6K150108Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20154—
+6K133924Endoluminal Occlusion System (Eos)Artventive Medical Group, Inc.20142—
+6K141313Reverse Medical Micro Vascular Plug SystemReverse Medical Corporation20145—
+6K133282Reverse Medical Micro Vascular Plug (MVP) SystemReverse Medical Corporation20136—
+7K253511Concerto Versa™ Detachable CoilMedtronic, Inc.20261—
+7K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular20230—
+7K213200Solus Gold Embolization DeviceArtio Medical, Inc.20220—
+7K191680AZUR Vascular PlugMicroVention, Inc.20200—
+7K181051IMPEDE Embolization Plug, 5mm, IMPEDE Embolization Plug, 7mm, IMPEDE Embolization Plug…Shape Memory Medical20181—
+7K150402Endoluminal Occlusion System-EOSArtventive Medical Group, Inc.20151—
+8K261866Concerto Versa™ Detachable CoilMedtronic, Inc.20260—
+8K212057Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOSArtventive Medical Group, Inc.20220—
+8K182390IMPEDE-FX Embolization PlugShape Memory Medical20190—