CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K030231
Device Name CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
Original Applicant
VITALCOR, INC.
100 east chestnut ave.
westmont, 
IL 
60559

Original Contact william huck
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 01/22/2003
Decision Date 04/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No