Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K103191 |
Device Name |
QUADROX-I PEDIATRIC MICROPOROUS MEMBRANE OXYGENATOR WITH INTEGRATED ARTERIAL FILTER WITH SOFTLINE / BIOLINE COATING |
Applicant |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Applicant Contact |
KATRIN SCHWENKGLENKS |
Correspondent |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Correspondent Contact |
KATRIN SCHWENKGLENKS |
Regulation Number | 870.4350
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 10/28/2010 |
Decision Date | 03/08/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|