510(k) Report

FDA applicant

Leocor, Inc.

Houston, TX4 decisions1990–19920 recalls

FDA records 4 decisions for Leocor, Inc. (Houston, TX) from 1990 to 1992: 3 510(k) clearances and 1 original PMA approval. Most are in product codes LOX (Catheters, Transluminal Coronary Angioplasty…) and DXK (Echocardiograph). 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 Leocor, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Leocor, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Leocor, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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