510(k) Report

FDA applicant

Jotec GmbH

Bozeman, MT1 decision2003–20030 recalls

FDA records 1 decision for Jotec GmbH (Bozeman, MT) in 2003: 1 510(k) clearance. All are in product code DSY (Prosthesis, Vascular Graft, Of 6mm And Greater…). 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 Jotec GmbH’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jotec GmbH since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Jotec GmbH 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?

  • DSYProsthesis, Vascular Graft, Of 6mm And Greater Diameter1decision

What has FDA decided for it lately?

  • K021547Flowline Biopore Eptfe Vascular GraftJotec GmbH · 2003

The one decision as Jotec GmbH →