510(k) Report

FDA applicant

Electro-Catheter Corp.

Mchenry, IL35 decisions1976–19950 recalls

FDA records 35 decisions for Electro-Catheter Corp. (Mchenry, IL) from 1976 to 1995: 35 510(k) clearances. Most are in product codes LDF (Electrode, Pacemaker, Temporary) and DRF (Catheter, Electrode Recording, Or Probe…). 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 Electro-Catheter Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Electro-Catheter Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Electro-Catheter”

FDA records each applicant name separately; these may or may not be the same firm.