510(k) K090891 ยท HCG Device, Neurovascular Embolization
MICROPLEX COIL SYSTEM-COSMOS
| Applicant | MicroVention, Inc., Aliso Viejo CA, US |
| Decision | Substantially Equivalent, Jun 22, 2009 |
| Received | Mar 30, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090891
| 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 |
| Nov 22, 2019 | Microvention, Inc. MicroVention Terumo Microplex 18, Platinum Embolization Coil, Cosmos 18, Sterile, Rx, REF numbers 180619CS-V, 180723CS-V, 180827CS-V, 180931CS-V, 181036CS-V, 181139CS-V, 181243CS-V, 181347CS-V, 181451 Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.