510(k) Report

FDA applicant

Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular

Irvine, CA3 decisions2021–20240 recalls

FDA records 3 decisions for Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular (Irvine, CA) from 2021 to 2024: 3 510(k) clearances. Most are in product codes DQY (Catheter, Percutaneous) and HCG (Device, Neurovascular Embolization). Its devices cite 4 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 Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12023: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQYCatheter, Percutaneous2decisions
  • HCGDevice, Neurovascular Embolization1decision

Whose devices does it build on?

Its devices cite 4 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 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.

  • K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 20212cite it

What has FDA decided for it lately?

  • K241177React 71 CatheterMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2024
  • K233420Axium Detachable Coil; Axium Prime Detachable CoilMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2023
  • K210230Phenom CathetersMicro Therapeutics Lnc. D/B/A Ev3 Neurovascular · 2021

All 3 as Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular →