MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100


Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K030141
Device Name MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100
Original Applicant
CARDIOVENTION, INC.
3045 stender way
santa clara, 
CA 
95054

Original Contact tessa yamut
Regulation Number 870.4220
Classification Product Code
DTQ  
Date Received 01/15/2003
Decision Date 02/26/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No