Ev3, Inc. - FDA 510(k) Cleared Devices
35
Total
26
Cleared
0
Denied
Ev3, Inc. — FDA 510(k) Products and Clearance History Cardiovascular ✕
25 devices
Cleared
Jul 18, 2014
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
Cardiovascular
79d
Cleared
Sep 26, 2013
NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER
Cardiovascular
21d
Cleared
May 24, 2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
Cardiovascular
52d
Cleared
Feb 12, 2013
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
Cardiovascular
85d
Cleared
Oct 27, 2011
SPIDERFX EMBOLIC PROTECTION DEVICE
Cardiovascular
199d
Cleared
Oct 27, 2011
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Cardiovascular
129d
Cleared
Sep 16, 2011
MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL...
Cardiovascular
108d
Cleared
Apr 14, 2011
EVERCROSS 0.035 OTW PTA DILATATION CATHETER
Cardiovascular
70d
Cleared
Jan 05, 2011
TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM
Cardiovascular
26d
Cleared
Dec 06, 2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
Cardiovascular
24d
Cleared
Feb 02, 2010
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER,...
Cardiovascular
22d
Cleared
Dec 09, 2009
ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER...
Cardiovascular
2d
Cleared
Nov 13, 2009
POWERCROSS .018 OTW PTA DILATION CATHETER
Cardiovascular
24d
Cleared
Nov 06, 2009
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM
Cardiovascular
16d
Cleared
Aug 07, 2009
TRAILBLAZER SUPPORT CATHETER
Cardiovascular
9d
Cleared
May 01, 2009
MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS...
Cardiovascular
32d
Cleared
Apr 16, 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
Cardiovascular
28d
Cleared
Dec 04, 2008
NANOCORSS .014 OTW PTA DILATATION CATHETER
Cardiovascular
66d
Cleared
Nov 20, 2008
EVERCROSS .035 OTW PTA DILATATION CATHETER
Cardiovascular
76d
Cleared
Jan 19, 2007
SPIDERFX EMBOLIC PROTECTION DEVICE
Cardiovascular
29d
Cleared
Nov 14, 2006
SPIDERFX EMBOLIC PROTECTION DEVICE
Cardiovascular
22d
Cleared
Aug 11, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
Cardiovascular
10d
Cleared
Jun 23, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
Cardiovascular
220d
Cleared
Feb 17, 2006
SPIDERX EMBOLIC PROTECTION DEVICE
Cardiovascular
143d
Cleared
Mar 02, 2004
MODIFICATION TO NITREX NITINOL GUIDEWIRE
Cardiovascular
19d