510(k) Report

FDA applicant

Intravascular Incorporated

Waukegan, IL2 decisions2002–20030 recalls

FDA records 2 decisions for Intravascular Incorporated (Waukegan, IL) from 2002 to 2003: 2 510(k) clearances. All are in product code FPA (Set, Administration, Intravascular). 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 Intravascular Incorporated’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Intravascular Incorporated since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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