EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION


Device Classification Name

catheter, continuous flush

510(k) Number K081467
Device Name EKOSONIC ENDOVASCULAR SYSTEM WITH RAPID PULSE MODULATION
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 05/27/2008
Decision Date 06/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls