EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
FDA 510(k) clearance K140151 · decided 2014-05-21
Clearance details
- K-number
- K140151
- Device name
- EKOSONIC MACH 4 ENDOVASCULAR DEVICE/EKOSONIC CONTROL UNIT
- Applicant
- Btg International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-01-22
- Decision date
- 2014-05-21
- Days to decision
- 119 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 |
|---|---|---|
| EkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main componen recall (Z-0864-2016) | EKOS Corporation | 2016-02-24 |
| The EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascu recall (Z-2148-2015) | EKOS Corporation | 2015-07-20 |