FDA 510(k) Applications Submitted by EV3 INC

FDA 510(k) Number Submission Date Device Name Applicant
K132777 09/05/2013 NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER EV3 INC
K111010 04/11/2011 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC
K111723 06/20/2011 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC
K062201 08/01/2006 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC
K093301 10/21/2009 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC
K103618 12/10/2010 TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM EV3 INC
K040345 02/12/2004 MODIFICATION TO NITREX NITINOL GUIDEWIRE EV3 INC
K111490 05/31/2011 MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS EV3 INC
K092299 07/29/2009 TRAILBLAZER SUPPORT CATHETER EV3 INC
K063204 10/23/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC
K063785 12/21/2006 SPIDERFX EMBOLIC PROTECTION DEVICE EV3 INC
K103322 11/12/2010 EVERCROSS 0.035 OTW PTA DILATION CATHETER EV3 INC
K032206 07/18/2003 PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION EV3 INC
K042204 08/16/2004 MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT EV3 INC
K032580 08/21/2003 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC
K052659 09/27/2005 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC
K033134 09/30/2003 MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM EV3 INC
K033314 10/15/2003 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC
K043243 11/23/2004 PRIMUS STENT AND DELIVERY SYSTEM EV3 INC
K100063 01/11/2010 HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL EV3 INC
K093750 12/07/2009 ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA EV3 INC
K141118 04/30/2014 NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER EV3 INC
K123544 11/19/2012 RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER EV3 INC
K040653 03/12/2004 PARAMOUNT MINI GPS BILIARY STENT SYSTEM EV3 INC
K061566 06/06/2006 PRIMUS GPS BILIARY STENT SYSTEM EV3 INC
K110319 02/03/2011 EVERCROSS 0.035 OTW PTA DILATATION CATHETER EV3 INC
K093286 10/20/2009 POWERCROSS .018 OTW PTA DILATION CATHETER EV3 INC


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