Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K183490 |
Device Name |
Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Balance Biosurface |
Applicant |
Medtronic Inc |
7611 Northland Dr |
Minneapolis,
MN
55428
|
|
Applicant Contact |
Wendy Pinor |
Correspondent |
Medtronic Inc |
7611 Northland Dr |
Minneapolis,
MN
55428
|
|
Correspondent Contact |
Wendy Pinor |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 12/17/2018 |
Decision Date | 04/12/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|