510(k) K081465 ยท KRD Device, Vascular, For Promoting Embolization
AXIUM DETACHABLE COIL SYSTEM
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Aug 19, 2008 |
| Received | May 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081465
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2012 | Micro Therapeutics Inc, dba ev3 Neurovascular Axium Detachable Coil System QC-2-1-Helix
The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as Terminated |
HCG | None listed |
| Jan 26, 2012 | Micro Therapeutics Inc, dba ev3 Neurovascular Axium Detachable Coil System QC-7-30-Helix
The ev3 Axium Detachable Coil System is indicated for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such a Terminated |
KRD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.