APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE

Endovascular Suturing System

APTUS ENDOSYSTEMS, INC.

The following data is part of a De Novo classification by Aptus Endosystems, Inc. with the FDA for Aptus Steerable Endoguide With Obturator, Aptus Endostaple Applier With Endostaple Cassette, Aptus Endostaple Cassette.

Pre-market Notification Details

DeNovo IDDEN100026
Device Name:APTUS STEERABLE ENDOGUIDE WITH OBTURATOR, APTUS ENDOSTAPLE APPLIER WITH ENDOSTAPLE CASSETTE, APTUS ENDOSTAPLE CASSETTE
ClassificationEndovascular Suturing System
Applicant APTUS ENDOSYSTEMS, INC. 777 N. Pastoria Ave. Sunnyvale,  CA  94085
ContactBurt Goodson
Product CodeOTD  
CFR Regulation Number870.3460 [🔎]
DecisionGranted (DENG)
510(k) Premarket NotificationK102333
Review Advisory BoardCardiovascular
Classification AdvisoryCardiovascular
TypePost-NSE
Date Received2010-12-14
Decision Date2011-11-21
FDA ReviewDecision Summary
Reclassification Order:Reclassification Order

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