APTUS HELI-FX AORTIC SECUREMENT SYSTEM

Endovascular Suturing System

APTUS ENDOSYSTEMS, INC.

The following data is part of a premarket notification filed by Aptus Endosystems, Inc. with the FDA for Aptus Heli-fx Aortic Securement System.

Pre-market Notification Details

Device IDK130677
510k NumberK130677
Device Name:APTUS HELI-FX AORTIC SECUREMENT SYSTEM
ClassificationEndovascular Suturing System
Applicant APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale,  CA  94089
ContactBurt Goodson
CorrespondentBurt Goodson
APTUS ENDOSYSTEMS, INC. 271 GIBRALTAR DRIVE Sunnyvale,  CA  94089
Product CodeOTD  
CFR Regulation Number870.3460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-03-13
Decision Date2013-04-12
Summary:summary

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