Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K112917 |
Device Name |
ATTAIN LDS 6216A LEFT HEART DELIVERY SYSTEM, ATTAIN ACCESS 6218A LEFT HEART DELIVERY SYSTEM, ATTAIN 6216A AND 6218A GUID |
Applicant |
MEDTRONIC, INC. |
8200 CORAL SEA STREET |
MS MVS11 |
MOUNDS VIEW,
MN
55112
|
|
Applicant Contact |
DEBORAH KIDDER |
Correspondent |
MEDTRONIC, INC. |
8200 CORAL SEA STREET |
MS MVS11 |
MOUNDS VIEW,
MN
55112
|
|
Correspondent Contact |
DEBORAH KIDDER |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 10/03/2011 |
Decision Date | 10/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|