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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, cannula and tubing, vascular, cardiopulmonary bypass
510(K) Number K033463
Device Name EDWARDS LIFESCIENCES RESEARCH MEDICAL PEDIATRIC ARTERIAL CANNULAE
Applicant
EDWARDS LIFESCIENCES LLC.
one edwards way
irvine,  CA  92614
Contact jason smith
Regulation Number870.4210
Classification Product Code
DWF  
Date Received10/31/2003
Decision Date 07/28/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product Yes
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