Device Classification Name |
Electrode, Pacemaker, Temporary
|
510(k) Number |
K963898 |
Device Name |
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
SUSAN NODDIN |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
SUSAN NODDIN |
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 09/27/1996 |
Decision Date | 07/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|