Device Classification Name |
Reservoir, Blood, Cardiopulmonary Bypass
|
510(k) Number |
K141432 |
Device Name |
NEONATAL VENOUS HARDSHELL CARDIOTOMY RESERVIOR, PEDIATRIC VENOUS HARDSHELL CARDIOTOMY RESERVIOR, NEONATAL VENOUS HARDHSH |
Applicant |
MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 |
RASTATT,
DE
76437
|
|
Applicant Contact |
KATRIN SCHWENKGLENKS |
Correspondent |
MAQUET CARDIOPULMONARY AG |
KEHLER STRASSE 31 |
RASTATT,
DE
76437
|
|
Correspondent Contact |
KATRIN SCHWENKGLENKS |
Regulation Number | 870.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/30/2014 |
Decision Date | 07/07/2014 |
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
|
|
|