COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR


the company

Device Classification Name

defoamer, cardiopulmonary bypass

510(k) Number K002591
Device Name COBE SMARXT VVR 4000 FILTERED HARDSHELL VENOUS RESERVOIR
Original Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada, 
CO 
80004

Original Contact lynne leonard
Regulation Number 870.4230
Classification Product Code
DTP  
Date Received 08/21/2000
Decision Date 09/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No