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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, percutaneous
510(k) Number K042850
Device Name CARDIODRIVE, MODEL 001-004115 (NON-STERILE); 001-1169-1 (STERILE)
Original Applicant
4041 forest park ave.
st. louis,  MO  63108
Original Contact gary rauvola
Regulation Number870.1250
Classification Product Code
Date Received10/15/2004
Decision Date 08/09/2006
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 No