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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