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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
Device Name APTUS 18FR HELIFX GUIDE-22 DEFLECTABLE LENGTH
Applicant
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale,  CA  94085
Applicant Contact burt goodson
Correspondent
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale,  CA  94085
Correspondent Contact burt goodson
Regulation Number870.3460
Classification Product Code
OTD  
Date Received04/17/2012
Decision Date 08/08/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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