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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(K) Number K121521
Device Name AXERA ACCESS SYSTEM
Applicant
ARSTASIS, INC.
740 bay rd
redwood city,  CA  94063
Contact debra cogan
Regulation Number870.1340
Classification Product Code
DYB  
Date Received05/23/2012
Decision Date 06/21/2012
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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