510(k) K203432 ยท HCG Device, Neurovascular Embolization
Axium Detachable Coil; Axium Prime Detachable Coil
| Applicant | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA, US |
| Decision | Substantially Equivalent, Jul 7, 2021 |
| Received | Nov 23, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203432
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2022 | Micro Therapeutics, Inc. AXIUM DETACHABLE COIL SYSTEM REF QC-4-12-HELIX;
Axium Detachable Coil System REF QC-10-30-3D; Open, Classified |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.