510(k) Report

FDA applicant

Cordis Leads, Inc.

Suffield, CT4 decisions1988–19880 recalls

FDA records 4 decisions for Cordis Leads, Inc. (Suffield, CT) in 1988: 4 510(k) clearances. Most are in product codes DTB (Permanent Pacemaker Electrode) and LDF (Electrode, Pacemaker, Temporary). 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 Cordis Leads, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Cordis Leads, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Cordis”

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