MODIFICATION TO ENDOWAVE INFUSION SYSTEM


Device Classification Name

catheter, continuous flush

510(k) Number K080392
Device Name MODIFICATION TO ENDOWAVE INFUSION SYSTEM
Applicant
EKOS CORP.
11911 n creek parkway south
bothell, 
WA 
98011

Applicant Contact jocelyn kersten
Correspondent
EKOS CORP.
11911 n creek parkway south
bothell, 
WA 
98011

Correspodent Contact jocelyn kersten
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 02/13/2008
Decision Date 04/30/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No