SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE


Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K103762
Device Name SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE
Applicant
SORIN GROUP DEUTSCHLAND GMBH
49 plain street
north attleboro, 
MA 
02760

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

Correspodent Contact rosina robinson, rn, med, rac
Regulation Number 870.4220
Classification Product Code
DTQ  
Date Received 12/23/2010
Decision Date 01/20/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No