IMPELLA CONTROLLER WITH FLOW CONTROL


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K110845
Device Name IMPELLA CONTROLLER WITH FLOW CONTROL
Applicant
ABIOMED, INC.
22 cherry hill dr.
danvers, 
MA 
01923

Applicant Contact robert stewart
Correspondent
ABIOMED, INC.
22 cherry hill dr.
danvers, 
MA 
01923

Correspodent Contact robert stewart
Regulation Number 870.4360
Classification Product Code
KFM  
Subsequent Product Code
DWA  
Date Received 03/28/2011
Decision Date 04/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No