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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name filter, intravascular, cardiovascular
510(K) Number K120402
Models 7014, 7015
Device Name CRUX VENA CAVA FILTER SYSTEM
Applicant
CRUX BIOMEDICAL
1455 adams drive, #1170
menlo park,  CA  94025
Contact elisa hebb
Regulation Number870.3375
Classification Product Code
DTK  
Date Received02/09/2012
Decision Date 07/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT01120509
NCT01120522
NCT01120535
Reviewed by Third Party No
Expedited Review No
Combination Product No
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