Device Classification Name |
pump, blood, cardiopulmonary bypass, non-roller type
|
510(k) Number |
K111972 |
Device Name |
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF |
Applicant |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
JESSICA SIXBERRY |
Correspondent |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
JESSICA SIXBERRY |
Regulation Number | 870.4360
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/11/2011 |
Decision Date | 07/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|