510(k) Report

FDA applicant

Avitro, LLC

Woodstock, IL2 decisions2000–20000 recalls

FDA records 2 decisions for Avitro, LLC (Woodstock, IL) in 2000: 2 510(k) clearances. All are in product code FOZ (Catheter, Intravascular, Therapeutic…). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Avitro, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Avitro, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days2decisions

Who builds on its devices?

Later devices cite its devices 1 time; 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.

  • K001795The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium VafdAvitro, LLC · 20001cites it

What has FDA decided for it lately?

  • K001795The Avitro LLC, 10 and 100 Uso Units/ML Heparin Sodium VafdAvitro, LLC · 2000
  • K0006320.9% Sodium Chloride Vasculat Access DeviceAvitro, LLC · 2000

All 2 as Avitro, LLC →