APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE

Endovascular Suturing System

APTUS ENDOSYSTEMS

The following data is part of a premarket notification filed by Aptus Endosystems with the FDA for Aptus Heli-fx Ancillary Endoanchor Cassette.

Pre-market Notification Details

Device IDK141041
510k NumberK141041
Device Name:APTUS HELI-FX ANCILLARY ENDOANCHOR CASSETTE
ClassificationEndovascular Suturing System
Applicant APTUS ENDOSYSTEMS 271 GIBRALTAR DR Sunnyvale,  CA  94089 -0000
ContactBurt Goodson
CorrespondentBurt Goodson
APTUS ENDOSYSTEMS 271 GIBRALTAR DR Sunnyvale,  CA  94089 -0000
Product CodeOTD  
CFR Regulation Number870.3460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-04-23
Decision Date2014-05-16
Summary:summary

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