510(k) K132317 ยท HCG Device, Neurovascular Embolization
MICROPLEX COIL SYSTEM (MCS), VFC
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Sep 20, 2013 |
| Received | Jul 25, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K132317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, HyperSoft 3D, Sterile, Rx, REF numbers 100102HS3D-V, 100103HS3D-V, 100152HS3D-V, 100153HS3D-V, 100154HS3D-V, 10 Terminated |
HCG | None listed |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex, Platinum Coil System, Endovascular Embolization Coil, VFC, Sterile, Rx, REF numbers MV-00306VFC, MV-00315VFC, MV-00310VFC, MV-00630VFC, VFC010303-V, VFC030606-V, VFC03 Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.