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Ev3, Inc.

35 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER (K141118)Ev3, Inc.2014-07-18
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER (K132777)Ev3, Inc.2013-09-26
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER (K130911)Ev3, Inc.2013-05-24
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER (K123544)Ev3, Inc.2013-02-12
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K111723)Ev3, Inc.2011-10-27
SPIDERFX EMBOLIC PROTECTION DEVICE (K111010)Ev3, Inc.2011-10-27
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL SINGLE COILED LENGTHS AND DISTAL SHAFT LENGTHS (K111490)Ev3, Inc.2011-09-16
EVERCROSS 0.035 OTW PTA DILATATION CATHETER (K110319)Ev3, Inc.2011-04-14
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM (K103618)Ev3, Inc.2011-01-05
EVERCROSS 0.035 OTW PTA DILATION CATHETER (K103322)Ev3, Inc.2010-12-06
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL (K100063)Ev3, Inc.2010-02-02
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER ULTRAFLOW HPC FLOW DIRECTED MICRO CATHETER, REBA (K093750)Ev3, Inc.2009-12-09
POWERCROSS .018 OTW PTA DILATION CATHETER (K093286)Ev3, Inc.2009-11-13
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM (K093301)Ev3, Inc.2009-11-06
TRAILBLAZER SUPPORT CATHETER (K092299)Ev3, Inc.2009-08-07
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 (K090849)Ev3, Inc.2009-05-01
HYPERGLIDE OCCLUSION BALLOON SYSTEM (K090728)Ev3, Inc.2009-04-16
NANOCORSS .014 OTW PTA DILATATION CATHETER (K082854)Ev3, Inc.2008-12-04
EVERCROSS .035 OTW PTA DILATATION CATHETER (K082579)Ev3, Inc.2008-11-20
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 (K072301)Ev3, Inc.2008-03-18
SPIDERFX EMBOLIC PROTECTION DEVICE (K063785)Ev3, Inc.2007-01-19
SPIDERFX EMBOLIC PROTECTION DEVICE (K063204)Ev3, Inc.2006-11-14
PRIMUS GPS BILIARY STENT SYSTEM (K061566)Ev3, Inc.2006-08-31
SPIDERX EMBOLIC PROTECTION DEVICE (K062201)Ev3, Inc.2006-08-11
SPIDERX EMBOLIC PROTECTION DEVICE (K053195)Ev3, Inc.2006-06-23
PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM (K060057)Ev3, Inc.2006-03-08
SPIDERX EMBOLIC PROTECTION DEVICE (K052659)Ev3, Inc.2006-02-17
PRIMUS STENT AND DELIVERY SYSTEM (K043243)Ev3, Inc.2004-12-09
MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENT (K042204)Ev3, Inc.2004-08-23
PARAMOUNT MINI GPS BILIARY STENT SYSTEM (K040653)Ev3, Inc.2004-04-28
MODIFICATION TO NITREX NITINOL GUIDEWIRE (K040345)Ev3, Inc.2004-03-02
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K033314)Ev3, Inc.2003-11-21
MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEM (K033134)Ev3, Inc.2003-11-17
PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM (K032580)Ev3, Inc.2003-10-22
PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATION (K032206)Ev3, Inc.2003-08-08

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