Ev3, Inc. - FDA 510(k) Cleared Devices

Cleared Jul 18, 2014

NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER

K141118 · LIT

Cardiovascular · 79d

Cleared Sep 26, 2013

NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHETER

K132777 · LIT

Cardiovascular · 21d

Cleared May 24, 2013

RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER

K130911 · LIT

Cardiovascular · 52d

Cleared Feb 12, 2013

RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER

K123544 · LIT

Cardiovascular · 85d

Cleared Oct 27, 2011

SPIDERFX EMBOLIC PROTECTION DEVICE

K111010 · NTE

Cardiovascular · 199d

Cleared Oct 27, 2011

TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM

K111723 · MCW

Cardiovascular · 129d

Cleared Sep 16, 2011

MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENGHTS, DISTAL...

K111490 · KRA

Cardiovascular · 108d

Cleared Apr 14, 2011

EVERCROSS 0.035 OTW PTA DILATATION CATHETER

K110319 · LIT

Cardiovascular · 70d

Cleared Jan 05, 2011

TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEM

K103618 · MCW

Cardiovascular · 26d

Cleared Dec 06, 2010

EVERCROSS 0.035 OTW PTA DILATION CATHETER

K103322 · LIT

Cardiovascular · 24d

Cleared Feb 02, 2010

HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER,...

K100063 · MJN

Cardiovascular · 22d

Cleared Dec 09, 2009

ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICRO CATHETER...

K093750 · KRA

Cardiovascular · 2d