DeviceClearance

EKOS PE Endovascular Device with Control System 4.0 (CS4.0)— 510(k) K200648

Substantially Equivalent

Ekos Corporation

FDA 510(k) clearance K200648 for EKOS PE Endovascular Device with Control System 4.0 (CS4.0), Substantially Equivalent on 2020-08-17. Applicant: Ekos Corporation.

Clearance details

Applicant
Ekos Corporation
Product code
Code QEY
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Bothell, WA, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.