510(k) Report

Devices descending from K090357

14 later devices reach Hydroframe (Hes) 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
+1K103758Microplex Coil System- Cosmos 10, Hydrocoil System- Hydroframe 10MicroVention, Inc.201171
+1K100454Hydrocoil Embolic System-Hydroframe Model 100931HFM-V, 101243HFM-V, 180827HFM-V…MicroVention, Inc.20109—
+2K153594MicroPlex Coil System (MCS), Hydrocoil Embolic System (HES)MicroVention, Inc.2016116
+2K131948Microplex Coil System (MCS)MicroVention, Inc.2013111
+2K123384Azur CX Detachable 18MicroVention, Inc.20123—
+2K112181Hydrocoil (R) Embolic System (Hes)MicroVention, Inc.20110—
+2K111451Microplex Coil System-Vector Model 030606XXX-V, 030610XXX-V, 30615XXX-V, 061020XXX-V…MicroVention, Inc.20114—
+3K223050AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060)MicroVention, Inc.20220—
+3K162524AZUR CX Detachable 18 Peripheral Coil SystemMicroVention, Inc.20171—
+3K161452MicroPlex Coil System (MCS) - HyperSoft 3DMicroVention, Inc.201601
+3K151358AZUR CX Detachable 35 CoilsMicroVention, Inc.201504
+3K132317Microplex Coil System (MCS), VFCMicroVention, Inc.201302