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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 K122585
Model 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 Received08/24/2012
Decision Date 01/17/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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