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U.S. Department of Health and Human Services

510(k) Premarket Notification

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1 to 9 of 9 Results
ProductCode: LIT Applicant: EV3 INC Decision Date To: 05/17/2024
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pacific plus pta catheter Medtronic Vascular,Inc(formerly d.b.a ev3 Inc.,Covidien llc) K202800 11/18/2020
evercrosstm 0.035 otw pta dilatation catheter Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) K190753 04/23/2019
nanocross eite 0.014 over-the-wire pta balloon dilatation catheter EV3 INC K141118 07/18/2014
nanocross elite .14 over-the-wire pta, balloon dilation catheter EV3 INC K132777 09/26/2013
rapidcross pta rapid exchange balloon dilatation catheter EV3 INC. K130911 05/24/2013
rapidcross pta rapid exchange, balloon dilatation catheter EV3 INC K123544 02/12/2013
evercross 0.035 otw pta dilatation catheter EV3 INC K110319 04/14/2011
evercross 0.035 otw pta dilation catheter EV3 INC K103322 12/06/2010
powercross .018 otw pta dilation catheter EV3 INC K093286 11/13/2009
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