EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700


Device Classification Name

catheter, ultrasound, intravascular

510(k) Number K073473
Device Name EAGLE EYE GOLD IVUS IMAGING CATHETER, MODEL 85900, AVABAR F/X IVUS IMAGING CATHETER, MODEL 85700
Applicant
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Applicant Contact arlene blades
Correspondent
VOLCANO CORPORATION
2870 kilgore rd.
rancho cordova, 
CA 
95670

Correspodent Contact arlene blades
Regulation Number 870.1200
Classification Product Code
OBJ  
Subsequent Product Code
ITX  
Date Received 12/11/2007
Decision Date 01/14/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No