Kaneka Medical America, LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 2
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K213166 | Thrombuster II Aspiration Catheter | October 26, 2021 |
| K210638 | i-ED COIL System | March 26, 2021 |