BIO-CONSOLE 560


Device Classification Name

control, pump speed, cardiopulmonary bypass

510(k) Number K080824
Device Name BIO-CONSOLE 560
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
minneapolis, 
MN 
55432

Applicant Contact preeti jain
Correspondent
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
minneapolis, 
MN 
55432

Correspodent Contact preeti jain
Regulation Number 870.4380
Classification Product Code
DWA  
Date Received 03/24/2008
Decision Date 05/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No