VIEWFLEX XTRA ICE CATHETER

Device Classification Name

system, imaging, pulsed echo, ultrasonic

510(k) Number K121381
Device Name VIEWFLEX XTRA ICE CATHETER
Applicant
ST. JUDE MEDICAL
one st. jude medical drive
st. paul, 
MN 
55117

Applicant Contact loucinda bjorklund
Correspondent
ST. JUDE MEDICAL
one st. jude medical drive
st. paul, 
MN 
55117

Correspodent Contact loucinda bjorklund
Regulation Number 892.1560
Classification Product Code
IYO  
Date Received 05/08/2012
Decision Date 06/07/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Radiology

510k Review Panel

Radiology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No