Device Classification Name |
oxygenator, cardiopulmonary bypass
|
510(k) Number |
K071774 |
Device Name |
JOSTRA QUADROX D DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODEL BE-HMOD 2000, BEQ-HMOD 2030 |
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 |
|
Date Received | 06/29/2007 |
Decision Date | 01/23/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|