Device Classification Name |
surgical device, for cutting, coagulation, and/or ablation of tissue, including cardiac tissue
|
510(k) Number |
K013392 |
Device Name |
CARDIOBLATE SURGICAL ABLATION PEN, MODEL 60811C; CARDIOBLATE SURGICAL ABLATION GENERATOR, MODEL 60880 |
Applicant |
MEDTRONIC VASCULAR |
1015 GRAMSIE RD |
SHOREVIEW,
MN
55126 -3082
|
|
Applicant Contact |
SCOTT CANDY |
Correspondent |
MEDTRONIC VASCULAR |
1015 GRAMSIE RD |
SHOREVIEW,
MN
55126 -3082
|
|
Correspondent Contact |
SCOTT CANDY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/15/2001 |
Decision Date | 01/25/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|