Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.1

Catheter, Intravascular, Diagnostic

Abbott Medical

The following data is part of a premarket notification filed by Abbott Medical with the FDA for Dragonfly Opstar™ Imaging Catheter, Aptivue™ Software Version E.5.1.

Pre-market Notification Details

Device IDK192019
501k NumberK192019
Device Name:Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software Version E.5.1
ClassificationCatheter, Intravascular, Diagnostic
Applicant Abbott Medical 4 Robbins Road Westford,  MA  01886
ContactRichard Demello
CorrespondentRichard Demello
Abbott Medical 4 Robbins Road Westford,  MA  01886
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelCardiovascular
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-29
Decision Date2019-11-08

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