510(k) Report

FDA applicant

Advanced Catheter Systems

Mchenry, IL5 decisions1982–19820 recalls

FDA records 5 decisions for Advanced Catheter Systems (Mchenry, IL) in 1982: 5 510(k) clearances. Most are in product codes DQO (Catheter, Intravascular, Diagnostic) and DYG (Catheter, Flow Directed). 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 Advanced Catheter Systems’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Advanced Catheter Systems since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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