Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K893459 |
Device Name |
PLASMA TFE VASCULAR PROSTHESIS (ALTER. PACKAGE) |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
DAVID H MUELLER |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
DAVID H MUELLER |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 05/03/1989 |
Decision Date | 09/20/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|