510(k) Report

FDA applicant

Ev3 Neurovascular

Irvine, CA4 decisions2005–20100 recalls

FDA records 4 decisions for Ev3 Neurovascular (Irvine, CA) from 2005 to 2010: 3 510(k) clearances and 1 original PMA approval. Most are in product codes MJN (Catheter, Intravascular Occluding, Temporary) and DQX (Wire, Guide, Catheter). Its devices cite 8 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Ev3 Neurovascular’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2009: 22010: 1
2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Ev3 Neurovascular by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • MJNCatheter, Intravascular Occluding, Temporary2decisions
  • DQXWire, Guide, Catheter1decision
  • MFEAgent, Injectable, Embolic1decision

Whose devices does it build on?

Its devices cite 8 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113…Ev3 Neurovascular · 20093cite it
  • K092495Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 20092cite it

What has FDA decided for it lately?

  • K093681Meridian GuidewireEv3 Neurovascular · 2010
  • K091458Hyperglide Occlusion Balloon System, Hyperform Occlusion Balloon System, Model 104-4112, 104-4113…Ev3 Neurovascular · 2009
  • K092495Hyperglide Occlusion Balloon System, Model 104-4310, 104-4315Ev3 Neurovascular · 2009
  • P030004Onyx Liquid Embolic SystemEv3 Neurovascular · 2005

All 4 as Ev3 Neurovascular →