SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K112050
Device Name SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER
Applicant
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar, 
CA 
91765

Applicant Contact marina guevrekian
Correspondent
BIOSENSE WEBSTER, INC.
3333 diamond canyon rd
diamond bar, 
CA 
91765

Correspodent Contact marina guevrekian
Regulation Number 870.1200
Classification Product Code
OBJ  
Date Received 07/18/2011
Decision Date 11/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No