EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
FDA 510(k) clearance K200648 · decided 2020-08-17
Clearance details
- K-number
- K200648
- Device name
- EKOS PE Endovascular Device with Control System 4.0 (CS4.0)
- Applicant
- Ekos Corporation
- Decision
- Substantially Equivalent
- Date received
- 2020-03-12
- Decision date
- 2020-08-17
- Days to decision
- 158 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Ekos Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
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 |