EKOSONIC ENDOVASCULAR SYSTEM


Device Classification Name

catheter, continuous flush

510(k) Number K111705
Device Name EKOSONIC ENDOVASCULAR SYSTEM
Applicant
EKOS CORPORATION
11911 north creek parkway south
bothell, 
WA 
98011

Applicant Contact jocelyn kersten
Correspondent
EKOS CORPORATION
11911 north creek parkway south
bothell, 
WA 
98011

Correspodent Contact jocelyn kersten
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 06/17/2011
Decision Date 08/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls