# Ev3 Neurovascular

- Location (FDA's records): Irvine, CA
- FDA decisions: 4 (2005–2010): 3 510(k) clearances and 1 original PMA approval
- Product codes: MJN (2), DQX (1), MFE (1)
- Predicates its devices cite: 8 (0 its own); citations of its devices by later devices: 5 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Micro Therapeutics, Inc.: 6 (https://510kreport.com/company/micro-therapeutics)
- Ev3, Inc.: 2 (https://510kreport.com/company/ev3)

## Firms that cite its devices most
- Ev3, Inc.: 2 (https://510kreport.com/company/ev3)
- Micro Therapeutics Dba Ev3 Neurovascular: 2 (https://510kreport.com/company/micro-therapeutics-dba-ev3-neurovascular)
- MicroVention, Inc.: 1 (https://510kreport.com/company/microvention)

## Its most-cited devices
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104 (2009), cited by 3
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 (2009), cited by 2

## Recent decisions
- K093681: Meridian Guidewire (Jan 26, 2010)
- K091458: Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113, 104-4127,104-4132,104 (Oct 15, 2009)
- K092495: Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315 (Sep 22, 2009)
- P030004: Onyx Liquid Embolic System (Jul 21, 2005)

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