Volcano Atheromed, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 7
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211518 | 2.4mm X 130cm Phoenix Deflecting Atherectomy System, 1.5mm X 149cm Phoenix Atherectomy System | June 14, 2021 |
| K193197 | QuickClear Mechanical Thrombectomy System | April 20, 2020 |
| K182972 | Phoenix Atherectomy System | December 20, 2018 |
| K181877 | Phoenix 2.4mm Atherectomy Plus System | December 17, 2018 |
| K172386 | 1.8mm X 149cm Phoenix Atherectomy System, 2.2mm X 149cm Phoenix Atherectomy System, 2.4mm X 130cm Ph | August 24, 2017 |
| K151145 | 2.4mm X 127 cm Phoenix Atherectomy Deflecting System | May 26, 2015 |
| K143328 | 1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Ha | December 19, 2014 |