Device Classification Name |
Oxygenator, Cardiopulmonary Bypass
|
510(k) Number |
K090511 |
Device Name |
QUADROX-I ADULT MICROPOROUS MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BEHMO70000,BEQ-HMO70000 |
Applicant |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Applicant Contact |
FRANK MOEHRKE |
Correspondent |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Correspondent Contact |
FRANK MOEHRKE |
Regulation Number | 870.4350
|
Classification Product Code |
|
Date Received | 02/26/2009 |
Decision Date | 06/12/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|