CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K080509
Device Name CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE
Applicant
MEDTRONIC INC.
7601 northland drive
minneapolis, 
MN 
55428

Applicant Contact preeti jain
Correspondent
MEDTRONIC INC.
7601 northland drive
minneapolis, 
MN 
55428

Correspodent Contact preeti jain
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 02/25/2008
Decision Date 05/05/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General & Plastic Surgery

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No