Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K021589 |
Device Name |
ATTAIN ACCESS 6218A LEFT-HEART DELIVERY SYSTEM, MODEL 6218 |
Applicant |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Applicant Contact |
KAREN REIDT |
Correspondent |
MEDTRONIC VASCULAR |
7000 CENTRAL AVE. N.E. |
MINNEAPOLIS,
MN
55432
|
|
Correspondent Contact |
KAREN REIDT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 05/15/2002 |
Decision Date | 05/30/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|