510(k) Report

Devices descending from K100454

9 later devices reach Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V… through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K161367HydroCoil Embolic System (HES)MicroVention, Inc.201604
+1K132952Microplex Coil System (MCS), Hydrocoil Embolic System (Hes)MicroVention, Inc.2013216
+1K123384Azur CX Detachable 18MicroVention, Inc.20123—
+1K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+2K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+2K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+2K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+3K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601