510(k) K103758 ยท HCG Device, Neurovascular Embolization
MICROPLEX COIL SYSTEM- COSMOS 10, HYDROCOIL SYSTEM- HYDROFRAME 10
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Apr 28, 2011 |
| Received | Dec 23, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K103758
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.