Device Classification Name |
Catheter, Flow Directed
|
510(k) Number |
K012225 |
Device Name |
ATTAIN 6215 VENOGRAM BALLOON CATHETER |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Applicant Contact |
KAREN REIDT |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. NE |
MINNEAPOLIS,
MN
55432 -3576
|
|
Correspondent Contact |
KAREN REIDT |
Regulation Number | 870.1240
|
Classification Product Code |
|
Date Received | 07/16/2001 |
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
|
|
|