# Ev3, Inc.

- Location (FDA's records): Plymouth, MN
- FDA decisions: 40 (2003–2014): 40 510(k) clearances
- Names in FDA's records: Ev3, Inc. (35); Ev3 Corporation (5)
- Product codes: FGE (12), LIT (7), MCW (4), DQY (4), NFA (3), NTE (3), DQX (3), MJN (2), KRA (2)
- Predicates its devices cite: 73 (27 its own); citations of its devices by later devices: 85 (27 its own)
- Recalls linked to its devices: 67 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Micro Therapeutics, Inc.: 14 (https://510kreport.com/company/micro-therapeutics)
- Flexmedics: 5 (https://510kreport.com/company/flexmedics)
- Boston Scientific Corp: 3 (https://510kreport.com/company/boston-scientific)
- Guidant Corp.: 2 (https://510kreport.com/company/guidant)
- Boston Scientific Epi: 2 (https://510kreport.com/company/boston-scientific-epi)
- Microvena Corp.: 2 (https://510kreport.com/company/microvena)
- Ev3 Neurovascular: 2 (https://510kreport.com/company/ev3-neurovascular)
- Foxhollow Technologies, Inc.: 2 (https://510kreport.com/company/foxhollow-technologies)

## Firms that cite its devices most
- Trireme Medical, Inc.: 8 (https://510kreport.com/company/trireme-medical)
- KANEKA Corporation: 4 (https://510kreport.com/company/kaneka)
- Medtronic, Inc.: 4 (https://510kreport.com/company/medtronic)
- Covidien: 4 (https://510kreport.com/company/covidien)
- Idev Technologies, Inc.: 3 (https://510kreport.com/company/idev-technologies)
- Invatec Innovative Technologies, S.R.L.: 3 (https://510kreport.com/company/invatec-innovative-technologies)
- Natec Medical, Ltd.: 2 (https://510kreport.com/company/natec-medical)
- Brosmed Medical Co., Ltd.: 2 (https://510kreport.com/company/brosmed-medical)

## Its most-cited devices
- K090849: Modification to: Nanocross 0.14 Otw Pta Dilatation Catheter, Models AB14W020210090, AB14W020210150 (2009), cited by 9
- K082579: Evercross .035 Otw Pta Dilatation Catheter (2008), cited by 6
- K093286: Powercross .018 Otw Pta Dilation Catheter (2009), cited by 5
- K052659: Spiderx Embolic Protection Device (2006), cited by 4
- K090728: Hyperglide Occlusion Balloon System (2009), cited by 4
- K060057: Protege Everflex Self-Expanding Biliary Stent System (2006), cited by 4

## Recent decisions
- K141118: Nanocross Eite 0.014 Over-the-Wire Pta Balloon Dilatation Catheter (Jul 18, 2014)
- K132777: Nanocross Elite .14 Over-the-Wire Pta, Balloon Dilation Catheter (Sep 26, 2013)
- K130911: Rapidcross Pta Rapid Exchange Balloon Dilatation Catheter (May 24, 2013)
- K123544: Rapidcross Pta Rapid Exchange, Balloon Dilatation Catheter (Feb 12, 2013)
- K111723: Turbohawk Peripheral Plaque Excision System (Oct 27, 2011)
- K111010: Spiderfx Embolic Protection Device (Oct 27, 2011)
- K111490: Marksman Catheter, *Refers to Different Catheter Working Lenghts, Distal Single Coiled Lengths and Distal Shaft Lengths (Sep 16, 2011)
- K110319: Evercross 0.035 Otw Pta Dilatation Catheter (Apr 14, 2011)

Source page: https://510kreport.com/company/ev3