MODIFICATION TO PROXIS SYSTEM


Device Classification Name

temporary coronary saphenous vein bypass graft for embolic protection

510(k) Number K073563
Device Name MODIFICATION TO PROXIS SYSTEM
Applicant
ST. JUDE MEDICAL
6550 wedgwood rd. north
suite 150
maple grove, 
MN 
55311

Applicant Contact linh pham
Correspondent
ST. JUDE MEDICAL
6550 wedgwood rd. north
suite 150
maple grove, 
MN 
55311

Correspodent Contact linh pham
Regulation Number 870.1250
Classification Product Code
NFA  
Date Received 12/19/2007
Decision Date 01/31/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No