Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K153295 |
Device Name |
TandemLung Oxygenator |
Applicant |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Applicant Contact |
GREG JOHNSON |
Correspondent |
CARDIAC ASSIST, INC. |
240 ALPHA DR. |
PITTSBURGH,
PA
15238
|
|
Correspondent Contact |
GREG JOHNSON |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 11/13/2015 |
Decision Date | 02/26/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|