FDA 510(k) Applications Submitted by EV3 INC.

FDA 510(k) Number Submission Date Device Name Applicant
K053195 11/15/2005 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC.
K072301 08/17/2007 5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05 EV3 INC.
K082579 09/05/2008 EVERCROSS .035 OTW PTA DILATATION CATHETER EV3 INC.
K082854 09/29/2008 NANOCORSS .014 OTW PTA DILATATION CATHETER EV3 INC.
K090728 03/19/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM EV3 INC.
K130911 04/02/2013 RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER EV3 INC.
K060057 01/09/2006 PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEM EV3 INC.
K090849 03/30/2009 MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 EV3 INC.


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