FX DETACHABLE COIL SYSTEM
FDA 510(k) clearance K060747 · decided 2007-04-24
Clearance details
- K-number
- K060747
- Device name
- FX DETACHABLE COIL SYSTEM
- Applicant
- Micro Therapeutics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-03-20
- Decision date
- 2007-04-24
- Days to decision
- 400 days
- Clearance type
- Traditional
- Product code
- HCG
- Device class
- 2
- Regulation number
- 882.5950
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Axium Detachable Coil System QC-2-1-Helix The ev3 Axium Detachable Coil System is indicate recall (Z-0873-2012) | Micro Therapeutics Inc, dba ev3 Neurovascular | 2012-01-26 |
| Axium Detachable Coil System Model Number: QC-2-2-3D. The AXIUM DETACHABLE COIL SYSTEM con recall (Z-0841-2012) | Micro Therapeutics Inc, dba ev3 Neurovascular | 2012-01-24 |