510(k) K161367 ยท HCG Device, Neurovascular Embolization
HydroCoil Embolic System (HES)
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | May 17, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161367
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, Helical, Sterile, Rx, REF numbers 100101H2HS-V; 100102H2HS-V, 100103H2HS-V, 100104H2HS-V, 100151H2HS-V; 1001 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroFrame 10, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 100306HFRM-V, 100405HFRM-V, 100408HFRM-V, 100410HFRM-V, 100412HFRM-V, 100415HFRM-V Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroFrame 18, HydroCoil Embolic System, Endovascular Embolization Coil, Sterile, Rx, REF numbers 180723HFRM-V, 180931HFRM-V, 181644HFRM-V, MV-80619HHFA, MV80827HHFA, MV-80931HHFA, Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo HydroSoft 10, HydroCoil Embolic System, Endovascular Embolization Coil, HydroSoft 3D, Sterile, Rx, REF numbers 100102HFRM-V, 100152HFRM-V, 100153HFRM-V, 100154HFRM-V, 100202HFRM-V, Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.