Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K121451 |
Device Name |
CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING , AND SENSING DEVICE |
Applicant |
MEDTRONIC INC. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Applicant Contact |
MARY DONLIN |
Correspondent |
MEDTRONIC INC. |
8200 Coral Sea Street NE |
Mounds View,
MN
55112
|
|
Correspondent Contact |
MARY DONLIN |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/16/2012 |
Decision Date | 06/14/2012 |
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
|
|
|