Device Classification Name |
Catheter, Flow Directed
|
510(k) Number |
K821004 |
Device Name |
MEDTRONIC S3 TM SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEDTRONIC VASCULAR |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 04/09/1982 |
Decision Date | 05/25/1982 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|