CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100


Device Classification Name

console, heart-lung machine, cardiopulmonary bypass

510(k) Number K021694
Device Name CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-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 05/22/2002
Decision Date 01/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No