SARN CENTRIFUGAL PUMP


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K112229
Device Name SARN CENTRIFUGAL PUMP
Applicant
TERUMO CARDIOVASCULAR SYSTEMS
6200 jackson rd
ann arbor, 
MI 
48103

Applicant Contact rebecca andersen
Correspondent
TERUMO CARDIOVASCULAR SYSTEMS
6200 jackson rd
ann arbor, 
MI 
48103

Correspodent Contact rebecca andersen
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 08/03/2011
Decision Date 12/09/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls