ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM


Device Classification Name

stylet, catheter

510(k) Number K072864
Device Name ST. JUDE MEDICAL, CPS DUO LEFT HEART LEAD DELIVERY SYSTEM
Applicant
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Applicant Contact colleen canan
Correspondent
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
15900 valley view ct.
sylmar, 
CA 
91342

Correspodent Contact colleen canan
Regulation Number 870.1380
Classification Product Code
DRB  
Subsequent Product Code
DQX  
Date Received 10/05/2007
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No