Atlas FDA

Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Ev3, Inc. — Predicate Candidate Screening

35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

37 daysmedian FDA review time
143 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141118NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CAEv3, Inc.2014-07-18791
K132777NANOCROSS ELITE .14 OVER-THE-WIRE PTA, BALLOON DILATION CATHEv3, Inc.2013-09-26210
K130911RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETEREv3, Inc.2013-05-24520
K123544RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETEREv3, Inc.2013-02-12850
K111723TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.2011-10-271290
K111010SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2011-10-271990
K111490MARKSMAN CATHETER, *REFERS TO DIFFERENT CATHETER WORKING LENEv3, Inc.2011-09-161080
K110319EVERCROSS 0.035 OTW PTA DILATATION CATHETEREv3, Inc.2011-04-14700
K103618TURBOHAWK PEROPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.2011-01-05260
K103322EVERCROSS 0.035 OTW PTA DILATION CATHETEREv3, Inc.2010-12-06241
K100063HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BEv3, Inc.2010-02-02220
K093750ECHELON MICRO CATHETER, MARATHON MICRO CATHETER, NAUTICA MICEv3, Inc.2009-12-0920
K093286POWERCROSS .018 OTW PTA DILATION CATHETEREv3, Inc.2009-11-13242
K093301TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEMEv3, Inc.2009-11-06160
K092299TRAILBLAZER SUPPORT CATHETEREv3, Inc.2009-08-0791
K090849MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER,Ev3, Inc.2009-05-01321
K090728HYPERGLIDE OCCLUSION BALLOON SYSTEMEv3, Inc.2009-04-16280
K082854NANOCORSS .014 OTW PTA DILATATION CATHETEREv3, Inc.2008-12-04661
K082579EVERCROSS .035 OTW PTA DILATATION CATHETEREv3, Inc.2008-11-20761
K0723015MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MOEv3, Inc.2008-03-182140
K063785SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2007-01-19290
K063204SPIDERFX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-11-14220
K061566PRIMUS GPS BILIARY STENT SYSTEMEv3, Inc.2006-08-31862
K062201SPIDERX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-08-11100
K053195SPIDERX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-06-232200
K060057PROTEGE EVERFLEX SELF-EXPANDING BILIARY STENT SYSTEMEv3, Inc.2006-03-08582
K052659SPIDERX EMBOLIC PROTECTION DEVICEEv3, Inc.2006-02-171430
K043243PRIMUS STENT AND DELIVERY SYSTEMEv3, Inc.2004-12-09163
K042204MODIFICATION TO PROTEGE GPS SELF-EXPANDING NITINOL STENTEv3, Inc.2004-08-2370
K040653PARAMOUNT MINI GPS BILIARY STENT SYSTEMEv3, Inc.2004-04-28470
K040345MODIFICATION TO NITREX NITINOL GUIDEWIREEv3, Inc.2004-03-02190
K033314PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEMEv3, Inc.2003-11-213711
K033134MODIFICATION TO PARAMOUNT MINI STENT AND DELIVERY SYSTEMEv3, Inc.2003-11-174836
K032580PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEMEv3, Inc.2003-10-22621
K032206PARAMOUNT MINI STENT AND DELIVERY SYSTEM BILIARY INDICATIONEv3, Inc.2003-08-08210

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda