Device Classification Name |
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
|
510(k) Number |
K090518 |
Device Name |
QUART ARTERIAL FILTER WITH SOFTLINE COATING |
Applicant |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Applicant Contact |
INGRID RICHTER |
Correspondent |
MAQUET CARDIOPULMONARY AG |
HECHINGER STRASSE 38 |
HIRRLINGEN,
DE
72145
|
|
Correspondent Contact |
INGRID RICHTER |
Regulation Number | 870.4260
|
Classification Product Code |
|
Date Received | 02/26/2009 |
Decision Date | 12/18/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
|
|