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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name endovascular suturing system
De Novo Number DEN100026
510(K) Number K102333
Device Name APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
Requester
APTUS ENDOSYSTEMS, INC.
777 n. pastoria ave.
sunnyvale,  CA  94085
Contact burt goodson
Regulation Number870.3460
Classification Product Code
OTD  
Date Received12/14/2010
Decision Date 11/21/2011
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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