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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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