SORIN CENTRIFUGAL PUMP 5 (CP5)


Device Classification Name

control, pump speed, cardiopulmonary bypass

510(k) Number K112225
Device Name SORIN CENTRIFUGAL PUMP 5 (CP5)
Applicant
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro, 
MA 
02760

Applicant Contact rosina robinson
Correspondent
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro, 
MA 
02760

Correspodent Contact rosina robinson
Regulation Number 870.4380
Classification Product Code
DWA  
Date Received 08/03/2011
Decision Date 09/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls