REVOLUTION 45MHZ IVUS IMAGING CATHETER


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K080891
Device Name REVOLUTION 45MHZ IVUS IMAGING CATHETER
Applicant
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Applicant Contact jennifer motto
Correspondent
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Correspodent Contact jennifer motto
Regulation Number 870.1200
Classification Product Code
OBJ  
Date Received 03/31/2008
Decision Date 05/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No