CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES


Device Classification Name

surgical device, for ablation of cardiac tissue

510(k) Number K121878
Device Name CARDIOBLATE CRYOFLEX SURGICAL ABLATION PROBES
Applicant
MEDTRONIC INC.
8200 coral sea street ne
mail stop mvs83
mounds view, 
MN 
55112

Applicant Contact kari christianson
Correspondent
MEDTRONIC INC.
8200 coral sea street ne
mail stop mvs83
mounds view, 
MN 
55112

Correspodent Contact kari christianson
Regulation Number 878.4400
Classification Product Code
OCL  
Date Received 06/28/2012
Decision Date 11/02/2012
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