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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name temporary carotid catheter for embolic capture
510(K) Number K121015
Model 22437-19, 22438-19, 22439-19, 22440-19, 22441-19, 22440-31
Device Name EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara,  CA  95054
Contact ivalee cohen
Regulation Number870.1250
Classification Product Code
NTE  
Date Received04/04/2012
Decision Date 05/04/2012
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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