Device Classification Name |
Permanent Pacemaker Electrode
|
510(k) Number |
K810333 |
Device Name |
TEMPORARY MYOCARDIAL PACING LEAD#6400 |
Applicant |
MEDTRONIC VASCULAR |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDTRONIC VASCULAR |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.3680
|
Classification Product Code |
|
Date Received | 02/09/1981 |
Decision Date | 03/13/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|