510(k) Report

FDA applicant

Bbraun

Evanston, IL1 decision2001–20011 recall

FDA records 1 decision for Bbraun (Evanston, IL) in 2001: 1 510(k) clearance. All are in product code DTK (Filter, Intravascular, Cardiovascular). 1 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 Bbraun’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Bbraun since 2007.

Recalls per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Bbraun 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?

  • DTKFilter, Intravascular, Cardiovascular1decision

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.

  • K010485Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave FilterBbraun · 20011cites it

What has FDA decided for it lately?

  • K010485Vena Tech Vena Cava Filter; Vena Tech 30D Vena Cava Filter; Vena Tech LP Cave FilterBbraun · 20011 recall

The one decision as Bbraun →

What has been recalled?

1 recall linked to its devices; the latest:

  • K010485Vena Tech LP Vena Cava Filter System, Item No/REF. 05010024, Model No: 40DLP, B Braun.…Oct 30, 2007