Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K012130 |
Device Name |
ATTAIN LDS 6216 LEFT-HEART DELIVERY SYSTEM |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
KAREN REIDT |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
KAREN REIDT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/09/2001 |
Decision Date | 08/28/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|