Medical Device Manufacturer · US , Bothell , WA

Ekos Corp. - FDA 510(k) Cleared Devices

23 submissions · 18 cleared · Since 2003

Recent clearances: EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION, EndoWave Infusion System, ENDOWAVE INFUSION SYSTEM

23
Total
18
Cleared
0
Denied

FDA 510(k) Regulatory Record - Ekos Corp. Cardiovascular ✕

19 devices
1-12 of 19
Cleared Jun 26, 2008
EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
K081467 · QEY
Cardiovascular · 30d
Cleared Apr 30, 2008
EndoWave Infusion System
K080392 · QEY
Cardiovascular · 77d
Cleared Apr 22, 2008
ENDOWAVE INFUSION SYSTEM
K073166 · KRA
Cardiovascular · 165d
Cleared Oct 04, 2007
ENDOWAVE INFUSION SYSTEM
K072507 · QEY
Cardiovascular · 28d
Cleared Aug 10, 2007
ENDOWAVE INFUSION SYSTEM
K071933 · QEY
Cardiovascular · 28d
Cleared Aug 06, 2007
EKOS MICRO-INFUSION SYSTEM
K063620 · QEY
Cardiovascular · 244d
Cleared Nov 22, 2006
MICRO-INFUSION SYSTEM
K062507 · QEY
Cardiovascular · 86d
Cleared Mar 09, 2006
LYSUS INFUSION SYSTEM
K060422 · QEY
Cardiovascular · 20d
Cleared Feb 07, 2006
LYSUS INFUSION SYSTEM
K060084 · QEY
Cardiovascular · 27d
Cleared Dec 30, 2005
EKOS MICRO-INFUSION SYSTEM
K053432 · QEY
Cardiovascular · 21d
Cleared Aug 16, 2005
LYSUS INFUSION SYSTEM
K052071 · QEY
Cardiovascular · 15d
Cleared Jun 15, 2005
LYSUS INFUSION SYSTEM
K051319 · QEY
Cardiovascular · 26d
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