510(k) K093919 ยท HCG Device, Neurovascular Embolization
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V
| Applicant | MicroVention, Inc., Tistin CA, US |
| Decision | Substantially Equivalent, Jan 21, 2010 |
| Received | Dec 22, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K093919
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 10, Platinum Coil System, Endovascular Embolization Coil, Cosmos 10, Sterile, Rx, REF numbers 100202CSSR-V, 100254CSSR-V, 100306CSSR-V, 100408CSSR-V, 100412CSSR-V, 10051 Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.