510(k) K060747 ยท HCG Device, Neurovascular Embolization
FX DETACHABLE COIL SYSTEM
| Applicant | Micro Therapeutics, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 24, 2007 |
| Received | Mar 20, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K060747
| 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 24, 2012 | Micro Therapeutics Inc, dba ev3 Neurovascular Axium Detachable Coil System Model Number: QC-2-2-3D.
The AXIUM DETACHABLE COIL SYSTEM consists of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque posit Terminated |
HCG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.