ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K080470
Device Name ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32
Applicant
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen, 

DE

72145

Applicant Contact katrin schwekglenks
Correspondent
MAQUET CARDIOPULMONARY AG
hechinger strasse 38
hirrlingen, 

DE

72145

Correspodent Contact katrin schwekglenks
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 02/21/2008
Decision Date 09/12/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No