EPICOR ABLATION SYSTEM


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K080292
Device Name EPICOR ABLATION SYSTEM
Applicant
ST. JUDE MEDICAL
1350 energy ln., suite 110
st. paul, 
MN 
55108

Applicant Contact karen j mckelvey
Correspondent
ST. JUDE MEDICAL
1350 energy ln., suite 110
st. paul, 
MN 
55108

Correspodent Contact karen j mckelvey
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 02/04/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls