VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM


Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K111706
Device Name VOLCANO S5IINTRAVASCULAR IMAGING AND PRESSURE SYSTEM
Applicant
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Applicant Contact jwala jawharkar
Correspondent
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Correspodent Contact jwala jawharkar
Regulation Number 892.1560
Classification Product Code
IYO  
Subsequent Product Codes
DSA   DSK  
Date Received 06/17/2011
Decision Date 07/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls