AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K111972
Device Name AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF
Applicant
MEDTRONIC INC.
7611 northland drive
minneapolis, 
MN 
55428

Applicant Contact jessica sixberry
Correspondent
MEDTRONIC INC.
7611 northland drive
minneapolis, 
MN 
55428

Correspodent Contact jessica sixberry
Regulation Number 870.4360
Classification Product Code
KFM  
Subsequent Product Codes
DPT   DRY   DTL   DTM   DTN  
DTR   DTZ   DWF  
Date Received 07/11/2011
Decision Date 07/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

Yes