Btg International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 6
- Inspections
- 1
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K191119 | EkoSonic Endovascular Device | August 23, 2019 |
| K183361 | EkoSonic Endovascular Device with Control Unit 4.0 | April 5, 2019 |
| K182324 | EkoSonic Endovascular System | November 26, 2018 |
| K172035 | EKOS ultrasound EVD Device, EVD Control Unit | March 24, 2018 |
| K162771 | EkoSonic Endovascular System with Control Unit 4.0 | February 24, 2017 |
| K140151 | EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT | May 21, 2014 |