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Ev3, Inc.

FDA 510(k) & PMA Approved Devices — 34 products

Total Devices34
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K132777 NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETERLIT2013-09-26 View
510(k) K130911 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETERLIT2013-05-24 View
510(k) K123544 RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETERLIT2013-02-12 View
510(k) K111010 SPIDERFX EMBOLIC PROTECTION DEVICENTE2011-10-27 View
510(k) K111723 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2011-10-27 View
510(k) K111490 MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHSKRA2011-09-16 View
510(k) K110319 EVERCROSS 0.035 OTW PTA DILATATION CATHETERLIT2011-04-14 View
510(k) K103618 TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMMCW2011-01-05 View
510(k) K103322 EVERCROSS 0.035 OTW PTA DILATION CATHETERLIT2010-12-06 View
510(k) K100063 HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODELMJN2010-02-02 View
510(k) K093750 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBAKRA2009-12-09 View
510(k) K093286 POWERCROSS .018 OTW PTA DILATION CATHETERLIT2009-11-13 View
510(k) K093301 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMMCW2009-11-06 View
510(k) K092299 TRAILBLAZER SUPPORT CATHETERDQY2009-08-07 View
510(k) K090849 MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150DQY2009-05-01 View
510(k) K090728 HYPERGLIDE OCCLUSION BALLOON SYSTEMMJN2009-04-16 View
510(k) K082854 NANOCORSS .014 OTW PTA DILATATION CATHETERDQY2008-12-04 View
510(k) K082579 EVERCROSS .035 OTW PTA DILATATION CATHETERDQY2008-11-20 View
510(k) K072301 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05FGE2008-03-18 View
510(k) K063785 SPIDERFX EMBOLIC PROTECTION DEVICENFA2007-01-19 View
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