EKOS Corporation

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
2
Inspections
5
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2890-2016Class IIThe EKOS cart has the catalog number 700-60101. The EKOS cart is a custom infusion stand/cart useAugust 22, 2016
Z-2854-2016Class IIEkoSonic Endovascular Devices EKOS Intelligent Drug Delivery CatheterAugust 9, 2016
Z-0864-2016Class IIEkoSonic Endovascular System, Catalog Number 500-56112. It consists of three main components, a sJanuary 21, 2016
Z-2148-2015Class IIThe EKOS EkoSonic Control Unit is intended exclusively for use with the EkoSonic Endovascular DeviceJune 24, 2015
Z-0133-2014Class IIThe EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average pOctober 2, 2013
Z-2023-2012Class IIEkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118; 500-55124; 500-55130; May 24, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K200648EKOS PE Endovascular Device with Control System 4.0 (CS4.0)August 17, 2020
K111705EKOSONIC ENDOVASCULAR SYSTEMAugust 3, 2011