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FDA 510(k) Applications Submitted by Rupali Gupta
FDA 510(k) Number
Submission Date
Device Name
Applicant
K161361
05/16/2016
HawkOne Directional Atherectomy System
Medtronic Vascular, Inc.
K142654
09/18/2014
Fortrex 0.035 OTW PTA Balloon Catheter
Covidien LLC
K202800
09/23/2020
Pacific Plus PTA Catheter
Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc)
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