Device Classification Name |
pump, blood, cardiopulmonary bypass, non-roller type
|
510(k) Number |
K090515 |
Device Name |
ROTAFLOW CENTRIFUGAL PUMP WITH SOFTLINE COATING, MODEL BO-RF-32 (USA) |
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 | 870.4360
|
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
|
Recalls |
CDRH Recalls
|
|
|