SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM


Device Classification Name

heat-exchanger, cardiopulmonary bypass

510(k) Number K021830
Device Name SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM
Original Applicant
COBE CARDIOVASCULAR, INC.
14401 west 65th way
arvada, 
CO 
80004

Original Contact shawn riedel
Regulation Number 870.4240
Classification Product Code
DTR  
Date Received 06/04/2002
Decision Date 07/02/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No