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FDA 510(k) Applications Submitted by Mugdha Dongre
FDA 510(k) Number
Submission Date
Device Name
Applicant
K160084
01/15/2016
Swan Ganz Catheters
Edwards Lifesciences, LLC
K191008
04/16/2019
iLab Polaris Multi-Modality Guidance System
Boston Scientific Corporation
K173284
10/16/2017
OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Boston Scientific Corporation
K173820
12/18/2017
OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (Paper DFU), OptiCross 6 HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Boston Scientific Corporation
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