COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700


Device Classification Name

pump, blood, cardiopulmonary bypass, non-roller type

510(k) Number K030462
Device Name COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700
Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada, 
CO 
80004

Applicant Contact charles copperberg
Correspondent
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada, 
CO 
80004

Correspodent Contact charles copperberg
Regulation Number 870.4360
Classification Product Code
KFM  
Date Received 02/12/2003
Decision Date 03/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls