EkoSonic Endovascular Device with Control Unit 4.0
FDA 510(k) clearance K183361 · decided 2019-04-05
Clearance details
- K-number
- K183361
- Device name
- EkoSonic Endovascular Device with Control Unit 4.0
- Applicant
- Btg International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2018-12-04
- Decision date
- 2019-04-05
- Days to decision
- 122 days
- Clearance type
- Traditional
- Product code
- QEY
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Bothell, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| EKOS Control Unit 4.0 console, a component of the EKOS Control System 4.0, which is a comp recall (Z-0149-2023) | Boston Scientific Corporation | 2022-10-28 |