Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K024035 |
Device Name |
ATTAIN 6218A-AM AMPLATZ GUIDE CATHETER FOR LEFT-HEART DELIVERY |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
LYNN JENSEN |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVENUE NE |
MS CW304 |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
LYNN JENSEN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 12/06/2002 |
Decision Date | 12/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|