Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K112360 |
Device Name |
QUADROX-I MICROPORPOROUS MEMBRANE OXGENATOR SERIES AND QUDROX-ID DIFFUSION MEMBRANE OXYGENATORS SERIES |
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 | 08/17/2011 |
Decision Date | 09/15/2011 |
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
|