Device Classification Name |
Electrode, Pacemaker, Temporary
|
510(k) Number |
K012460 |
Device Name |
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
TINA BENOIT |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
TINA BENOIT |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 08/01/2001 |
Decision Date | 08/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|