510(k) K161452 ยท HCG Device, Neurovascular Embolization
MicroPlex Coil System (MCS) - HyperSoft 3D
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | May 26, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161452
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.