AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K111658
Device Name AFFINITY CP CENTRIFUGAL BLLOD PUMP WITH CARMEDA BIOACTIVE SURFACE
Applicant
MEDTRONIC INC.
8200 coral sea st ne
mounds view, 
MN 
55112

Applicant Contact lisa stone
Correspondent
MEDTRONIC INC.
8200 coral sea st ne
mounds view, 
MN 
55112

Correspodent Contact lisa stone
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 06/14/2011
Decision Date 06/28/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes