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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: DQY Applicant: EV3 INC Decision Date To: 04/25/2024
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evercrosstm 0.035 otw pta dilatation catheter Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) K190753 04/23/2019
trailblazer angled support catheter Medtronic Vascular, Inc.(formerly ev3 Inc.) K162384 09/22/2016
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
powercross .018 otw pta dilation catheter EV3 INC K093286 11/13/2009
trailblazer support catheter EV3 INC K092299 08/07/2009
modification to: nanocross 0.14 otw pta dilatation catheter, models ab14w020210090, ab14w020210150 EV3 INC. K090849 05/01/2009
nanocorss .014 otw pta dilatation catheter EV3 INC. K082854 12/04/2008
evercross .035 otw pta dilatation catheter EV3 INC. K082579 11/20/2008
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