Device Classification Name |
reservoir, blood, cardiopulmonary bypass
|
510(k) Number |
K132972 |
Device Name |
AFFINITY FUSION CARDIOTOMY/VENOUS RESERVOIR WITH BALANCE BIOSURFACE |
Applicant |
MEDTRONIC, INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
JULIA A NELSON |
Correspondent |
MEDTRONIC, INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
JULIA A NELSON |
Regulation Number | 870.4400
|
Classification Product Code |
|
Date Received | 09/23/2013 |
Decision Date | 10/28/2013 |
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
|
|
|