Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K123314 |
Device Name |
AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE |
Applicant |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Applicant Contact |
MARY E DONLIN |
Correspondent |
MEDTRONIC INC. |
7611 NORTHLAND DRIVE |
MINNEAPOLIS,
MN
55428
|
|
Correspondent Contact |
MARY E DONLIN |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 10/25/2012 |
Decision Date | 01/22/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|