6F PROXIS SYSTEM


Device Classification Name

catheter, percutaneous

510(k) Number K073700
Device Name 6F PROXIS SYSTEM
Applicant
ST. JUDE MEDICAL, INC.
6500 wedgwood rd. north
maple grove, 
MN 
55311

Applicant Contact linh pham
Correspondent
ST. JUDE MEDICAL, INC.
6500 wedgwood rd. north
maple grove, 
MN 
55311

Correspodent Contact linh pham
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 12/31/2007
Decision Date 10/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No