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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name endovascular suturing system
510(k) Number K121168
Models HA-18, HG-18-22, HG-18-32, HG-18-42
Device Name APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Original Applicant
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale,  CA  94085
Original Contact burt goodson
Regulation Number870.3460
Classification Product Code
OTD  
Date Received04/17/2012
Decision Date 08/08/2012
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
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