Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K123733 |
Device Name |
CARDIOBLATE CRYOFLEX SURGICAL ABLATION SYSTEM |
Applicant |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MS MVS83 |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
KARI CHRISTIANSON |
Correspondent |
MEDTRONIC INC. |
8200 CORAL SEA STREET NE |
MS MVS83 |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
KARI CHRISTIANSON |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 12/05/2012 |
Decision Date | 04/01/2013 |
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
|
Recalls |
CDRH Recalls
|
|
|